Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04229303
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2019-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001229', 'term': 'Aspergillosis, Allergic Bronchopulmonary'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065819', 'term': 'Voriconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@zambongroup.com', 'phone': '+39 02 665241', 'title': 'Arnd Mueller, MD', 'organization': 'Zambon SpA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Throughout Part 1 (Day 1, Day 2, Day 3 by phone, Day 5 on return visit) until Days 9-13 by follow-up phone calls. Throughout Part 2 from Day 1 to Day 11, on Day 14 and Day 17 on return visits until Days 11-17 after the last dose by follow-up phone calls. Throughout Part 3 from Day 1 until Day 4', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Catheter site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'FEV decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG004', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG005', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG006', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG007', 'title': 'Part 3 - ZP-059 20mg', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG008', 'title': 'Part 3 - Oral Voriconazole 200mg', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'Total number of subjects with at least 1 TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'Total number of subjects with at least 1 serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Total number of subjects with at least 1 mild TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Total number of subjects with at least 1 moderate TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Total number of subjects with at least 1 severe TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Total number of subjects with at least 1 treatment-related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Total number of subjects with at least 1 non treatment-related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: screening (Day -28 to -1) to follow-up (8 to 12 days after last dose); part 2: screening (Day -28 to -1) to follow-up (11-17 days after last dose); Part 3: screening (Day -28 to -1) to follow-up (8-12 days after last dose of study drug).', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of IMP, whether or not considered related to the study IMP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF): subjects who received at least 1 IMP dose, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'AUC0-t, AUC0-inf for Voriconazole and N-oxide Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'AUC0-t Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.36', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '73.89', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '187.76', 'spread': '1.35', 'groupId': 'OG002'}, {'value': '328.37', 'spread': '1.19', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-t N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '298.15', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '573.55', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '804.24', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '1835.81', 'spread': '1.09', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-inf Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40.00', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '78.94', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '203.96', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '377.19', 'spread': '1.20', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-inf N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '337.40', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '652.99', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '865.80', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '1977.21', 'spread': '1.11', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.62', 'ciLowerLimit': '0.424', 'ciUpperLimit': '0.821', 'groupDescription': 'Statistics for Voriconazole AUC0-t', 'statisticalMethod': 'General power constant model', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0363', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.21', 'ciLowerLimit': '1.050', 'ciUpperLimit': '1.362', 'groupDescription': 'Statistics for Voriconazole AUC0-t', 'statisticalMethod': 'General power linear model', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '13.48', 'ciLowerLimit': '10.096', 'ciUpperLimit': '17.994', 'groupDescription': 'Statistics for Voriconazole AUC0-t, 40mg vs 5mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.85', 'ciLowerLimit': '1.728', 'ciUpperLimit': '1.963', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-t', 'statisticalMethod': 'General power constant model', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0201', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.87', 'ciLowerLimit': '0.789', 'ciUpperLimit': '0.960', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-t', 'statisticalMethod': 'General power linear model', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.16', 'ciLowerLimit': '5.253', 'ciUpperLimit': '7.217', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-t, 40mg vs 5mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.81', 'ciLowerLimit': '0.661', 'ciUpperLimit': '0.958', 'groupDescription': 'Statistics for Voriconazole AUC0-inf', 'statisticalMethod': 'General power constant model', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1278', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.12', 'ciLowerLimit': '0.990', 'ciUpperLimit': '1.245', 'groupDescription': 'Statistics for Voriconazole AUC0-inf', 'statisticalMethod': 'General power linear model', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.43', 'ciLowerLimit': '6.834', 'ciUpperLimit': '13.012', 'groupDescription': 'Statistics for Voriconazole AUC0-inf, 40mg vs 5mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.98', 'ciLowerLimit': '1.860', 'ciUpperLimit': '2.106', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-inf', 'statisticalMethod': 'General power constant model', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0082', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.79', 'ciLowerLimit': '0.670', 'ciUpperLimit': '0.912', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-inf', 'statisticalMethod': 'General power linear model', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.86', 'ciLowerLimit': '4.627', 'ciUpperLimit': '7.421', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-inf, 40mg vs 5mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'AUC0-t = Area under the serum concentration time curve from time 0 to time t (hours) (AUC0-t) (AUC0-12 for Part 1) AUC0-inf = Area under the serum concentration time curve from time 0 to infinity', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Cmax for Voriconazole and N-oxide Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'categories': [{'measurements': [{'value': '8.44', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '18.52', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '53.37', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '94.33', 'spread': '1.18', 'groupId': 'OG003'}]}]}, {'title': 'N-oxide voriconazole', 'categories': [{'measurements': [{'value': '57.70', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '103.16', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '145.79', 'spread': '1.30', 'groupId': 'OG002'}, {'value': '286.63', 'spread': '1.15', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2575', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.12', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.308', 'groupDescription': 'Statistics for Voriconazole Cmax', 'statisticalMethod': 'General power constant model', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0491', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.17', 'ciLowerLimit': '1.030', 'ciUpperLimit': '1.316', 'groupDescription': 'Statistics for Voriconazole Cmax', 'statisticalMethod': 'General power linear model', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.17', 'ciLowerLimit': '8.435', 'ciUpperLimit': '14.803', 'groupDescription': 'Statistics for Voriconazole Cmax, 40mg vs 5mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.25', 'ciLowerLimit': '1.135', 'ciUpperLimit': '1.363', 'groupDescription': 'Statistics for N-oxide Voriconazole Cmax', 'statisticalMethod': 'General power constant model', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.74', 'ciLowerLimit': '0.634', 'ciUpperLimit': '0.843', 'groupDescription': 'Statistics for N-oxide Voriconazole Cmax', 'statisticalMethod': 'General power linear model', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.97', 'ciLowerLimit': '3.946', 'ciUpperLimit': '6.254', 'groupDescription': 'Statistics for N-oxide Voriconazole Cmax, 40mg vs 5mg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given;', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Tmax and T1/2 for Voriconazole and N-oxide Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Tmax Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG003'}]}]}, {'title': 'Tmax N-oxide voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.85', 'spread': '1.29', 'groupId': 'OG002'}, {'value': '1.65', 'spread': '1.15', 'groupId': 'OG003'}]}]}, {'title': 'T1/2 Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '3.20', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '3.63', 'spread': '1.22', 'groupId': 'OG003'}]}]}, {'title': 'T1/2 N-oxide voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.60', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '3.38', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '4.43', 'spread': '1.26', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Tmax= Time to maximum concentration (Cmax). T 1/2 = Elimination half-life: the time taken for the plasma concentration to fall by half its original value.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Kel for Voriconazole and N-oxide Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '1.22', 'groupId': 'OG003'}]}]}, {'title': 'N-oxide voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '0.16', 'spread': '1.26', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Kel (Elimination rate constant): is a value used to describe the rate at which a drug is removed from the human system.\n\nIt is equivalent to the fraction of a substance that is removed per unit time measured at any particular instant and has units of 1/h.', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'CL/F for Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'categories': [{'measurements': [{'value': '131.2', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '124.6', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '97.7', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '108.7', 'spread': '1.22', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Apparent clearance: Equal to the drug dose divided by the area-under-the-curve; is an important pharmacokinetic parameter and plays an important role in the selection of a safe and tolerable dose for first-in-human studies.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Vz/F for Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'categories': [{'measurements': [{'value': '614.3', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '553.1', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '450.9', 'spread': '1.25', 'groupId': 'OG002'}, {'value': '569.6', 'spread': '1.20', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Vz/F=Apparent volume of distribution during terminal phase.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'MR AUC0-t, MR AUC0-inf for N-oxide Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'MR AUC0-t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.25', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '7.76', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '4.28', 'spread': '1.43', 'groupId': 'OG002'}, {'value': '5.59', 'spread': '1.14', 'groupId': 'OG003'}]}]}, {'title': 'MR AUC0-inf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.92', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '8.18', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '4.92', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '6.12', 'spread': '1.08', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nArea under the serum concentration time curve from time 0 to time t (hours) (AUC0-t)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'MR Cmax for N-oxide Voriconazole - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.84', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '2.73', 'spread': '1.51', 'groupId': 'OG002'}, {'value': '3.04', 'spread': '1.31', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nCmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'AUC0-t, AUC0-inf for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'AUC0-t Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69.65', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '139.29', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '329.28', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-inf Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.20', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '155.72', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '358.13', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-t Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.00', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '256.04', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '480.22', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-inf Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.78', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '258.66', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '493.04', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-t N-oxide Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '391.28', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '769.65', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '1990.76', 'spread': '1.23', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-inf N-oxide Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '439.14', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '849.27', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2001.85', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-t N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '728.68', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1784.63', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '3353.43', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-inf N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '752.99', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '1807.93', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '3174.66', 'spread': '1.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.00', 'ciLowerLimit': '1.528', 'ciUpperLimit': '2.617', 'groupDescription': 'Statistics for Voriconazole AUC0-t Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.73', 'ciLowerLimit': '3.612', 'ciUpperLimit': '6.187', 'groupDescription': 'Statistics for Voriconazole AUC0-t Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.81', 'ciLowerLimit': '2.017', 'ciUpperLimit': '3.925', 'groupDescription': 'Statistics for Voriconazole AUC0-t day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.28', 'ciLowerLimit': '3.783', 'ciUpperLimit': '7.361', 'groupDescription': 'Statistics for Voriconazole AUC0-t Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.97', 'ciLowerLimit': '1.615', 'ciUpperLimit': '2.396', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-t Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.09', 'ciLowerLimit': '4.178', 'ciUpperLimit': '6.196', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-t Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.45', 'ciLowerLimit': '1.791', 'ciUpperLimit': '3.349', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-t Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.60', 'ciLowerLimit': '3.365', 'ciUpperLimit': '6.294', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-t Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.99', 'ciLowerLimit': '1.524', 'ciUpperLimit': '2.602', 'groupDescription': 'Statistics for Voriconazole AUC0-inf Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.58', 'ciLowerLimit': '3.505', 'ciUpperLimit': '5.984', 'groupDescription': 'Statistics for Voriconazole AUC0-inf Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.65', 'ciLowerLimit': '1.851', 'ciUpperLimit': '3.781', 'groupDescription': 'Statistics for Voriconazole AUC0-inf Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.04', 'ciLowerLimit': '3.587', 'ciUpperLimit': '7.088', 'groupDescription': 'Statistics for Voriconazole AUC0-inf Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.93', 'ciLowerLimit': '1.569', 'ciUpperLimit': '2.384', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-inf Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.56', 'ciLowerLimit': '3.608', 'ciUpperLimit': '5.759', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-inf Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.40', 'ciLowerLimit': '1.694', 'ciUpperLimit': '3.402', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-inf Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.22', 'ciLowerLimit': '2.975', 'ciUpperLimit': '5.974', 'groupDescription': 'Statistics for N-oxide Voriconazole AUC0-inf Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'AUC0-t = Area under the serum concentration time curve from time 0 to time t (hours) (AUC0-t) (AUC0-24 for Part 2) AUC0-inf = Area under the serum concentration time curve from time 0 to infinity', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Cmax for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole - Day 1', 'categories': [{'measurements': [{'value': '19.87', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '40.42', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '96.77', 'spread': '1.16', 'groupId': 'OG002'}]}]}, {'title': 'Voriconazole - Day 10', 'categories': [{'measurements': [{'value': '21.38', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '57.11', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '127.54', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole - Day 1', 'categories': [{'measurements': [{'value': '71.66', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '144.43', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '339.11', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole - Day 10', 'categories': [{'measurements': [{'value': '102.78', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '217.76', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '412.40', 'spread': '1.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.03', 'ciLowerLimit': '1.562', 'ciUpperLimit': '2.650', 'groupDescription': 'Statistics for Voriconazole Cmax Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.87', 'ciLowerLimit': '3.740', 'ciUpperLimit': '6.345', 'groupDescription': 'Statistics for Voriconazole Cmax Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.67', 'ciLowerLimit': '2.081', 'ciUpperLimit': '3.429', 'groupDescription': 'Statistics for Voriconazole Cmax Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.97', 'ciLowerLimit': '4.647', 'ciUpperLimit': '7.658', 'groupDescription': 'Statistics for Voriconazole Cmax Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.02', 'ciLowerLimit': '1.688', 'ciUpperLimit': '2.406', 'groupDescription': 'Statistics for N-oxide Voriconazole Cmax Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.73', 'ciLowerLimit': '3.964', 'ciUpperLimit': '5.650', 'groupDescription': 'Statistics for N-oxide Voriconazole Cmax Day 1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.12', 'ciLowerLimit': '1.655', 'ciUpperLimit': '2.711', 'groupDescription': 'Statistics for N-oxide Voriconazole Cmax Day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.01', 'ciLowerLimit': '3.135', 'ciUpperLimit': '5.135', 'groupDescription': 'Statistics for N-oxide Voriconazole Cmax day 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given;', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Tmax and T1/2 for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Tmax Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.57', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Tmax Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Tmax N-oxide Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.65', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'Tmax N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '1.45', 'groupId': 'OG002'}]}]}, {'title': 'T1/2 Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.60', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '3.24', 'spread': '1.08', 'groupId': 'OG002'}]}]}, {'title': 'T1/2 Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.40', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '5.15', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '4.48', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'T1/2 N-oxide Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.45', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '3.82', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'T1/2 N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.52', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '5.04', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '4.14', 'spread': '1.21', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Tmax= Time to maximum concentration (Cmax). T 1/2 = Elimination half-life: the time taken for the plasma concentration to fall by half its original value.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Kel for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '1.08', 'groupId': 'OG002'}]}]}, {'title': 'Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '1.21', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Kel (Elimination rate constant): is a value used to describe the rate at which a drug is removed from the human system.\n\nIt is equivalent to the fraction of a substance that is removed per unit time measured at any particular instant and has units of 1/h.', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'CL/F for Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'categories': [{'measurements': [{'value': '120.9', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '93.5', 'spread': '1.25', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Apparent clearance: Equal to the drug dose divided by the area-under-the-curve; is an important pharmacokinetic parameter and plays an important role in the selection of a safe and tolerable dose for first-in-human studies.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Swing for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'categories': [{'measurements': [{'value': '10.50', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '9.62', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '55.16', 'spread': '1.63', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole', 'categories': [{'measurements': [{'value': '4.60', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '20.65', 'spread': '2.70', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Swing for voriconazole and N-oxide voriconazole = \\[(Cmax - Cmin) / Cmin\\]\\*100%', 'unitOfMeasure': 'percentage concentration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'AUCtau for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'categories': [{'measurements': [{'value': '82.82', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '215.56', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '427.57', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole', 'categories': [{'measurements': [{'value': '620.89', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '1438.74', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '2803.51', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Area under the serum concentration time curve for the dosing interval', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Css,av for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'categories': [{'measurements': [{'value': '6.91', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '17.95', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '35.64', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole', 'categories': [{'measurements': [{'value': '51.75', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '119.88', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '233.63', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': "Css,av or Css(ave): Average drug concentration at steady state; Steady-state concentration (Css) occurs when the amount of a drug being absorbed is the same amount that's being cleared from the body when the drug is given continuously or repeatedly", 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Fluctuation for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'categories': [{'measurements': [{'value': '281.0', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '284.9', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '350.8', 'spread': '1.10', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole', 'categories': [{'measurements': [{'value': '162.8', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '141.8', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '163.8', 'spread': '1.30', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Peak trough fluctuation in serum concentrations within one dosing interval at steady state. Fluctuation - Over the Dosing Interval - is expressed as percentage concentration.', 'unitOfMeasure': 'percentage concentration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Rac for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'categories': [{'measurements': [{'value': '1.19', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole', 'categories': [{'measurements': [{'value': '1.59', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.41', 'spread': '1.10', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Accumulation ratio. The drug accumulation ratio (Rac) is the ratio of accumulation of a drug under steady state conditions as compared to a single dose. The higher the value, the more the drug accumulates in the body. An Rac of 1 means no accumulation.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Rlinear for Voriconazole and N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '1.17', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Rlinear means linearity ratio for Area Under the Serum Concentration-Time Curve from time zero to infinity.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'MR AUC0-t, MR AUC0-inf and MR AUCtau for N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'MR AUC0-t N-oxide Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.62', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '6.04', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': 'MR AUC0-inf N-oxide Voriconazole - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.68', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '5.55', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': 'MR AUC0-t N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.01', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '6.98', 'spread': '1.16', 'groupId': 'OG002'}]}]}, {'title': 'MR AUC0-inf N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.70', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '6.99', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '7.11', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': 'MR AUCtau N-oxide Voriconazole - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.50', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '6.68', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '6.56', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nArea under the serum concentration time curve from time 0 to time t (hours) (AUC0-t)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'MR Cmax N-oxide Voriconazole - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'title': 'N-oxide Voriconazole - Day 1', 'categories': [{'measurements': [{'value': '3.61', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '3.50', 'spread': '1.22', 'groupId': 'OG002'}]}]}, {'title': 'N-oxide Voriconazole - Day 10', 'categories': [{'measurements': [{'value': '4.81', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '3.23', 'spread': '1.37', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nCmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Cmax for Voriconazole and N-oxide Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'Voriconazole', 'categories': [{'measurements': [{'value': '108.08', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '863.22', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'N-oxide Voriconazole', 'categories': [{'measurements': [{'value': '151.43', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1589.05', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given;', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Vz/F for Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}], 'classes': [{'categories': [{'measurements': [{'value': '767.1', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '714.3', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '604.9', 'spread': '1.13', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Only at Day 10', 'description': 'Vz/F=Apparent volume of distribution during terminal phase.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'AUC0-t, AUC0-inf for Voriconazole and N-oxide Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'AUC0-t Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '290.02', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '3726.68', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-inf Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '269.61', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '3800.41', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-t N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1128.69', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '21504.52', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-inf N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1154.35', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '21788.46', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'AUC0-t = Area under the serum concentration time curve from time 0 to time t (hours) (AUC0-t) (AUC0-96 for Part 3) AUC0-inf = Area under the serum concentration time curve from time 0 to infinity', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Tmax and T1/2 for Voriconazole and N-oxide Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'Tmax Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Tmax N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.74', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'T1/2 Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.13', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '6.93', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'T1/2 N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.68', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2 (Pre-dose, 0.25h, 0.75h 1.5h, 2h ,3h ,4h ,6h ,8h ,12h ,16h , 24h ,48h after dosing)', 'description': 'Tmax= Time to maximum concentration (Cmax). T 1/2 = Elimination half-life: the time taken for the plasma concentration to fall by half its original value.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'CL/F for Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '52.4', 'spread': '1.93', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Apparent clearance: Equal to the drug dose divided by the area-under-the-curve; is an important pharmacokinetic parameter and plays an important role in the selection of a safe and tolerable dose for first-in-human studies.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Kel for Voriconazole and N-oxide Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'N-oxide Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Kel (Elimination rate constant): is a value used to describe the rate at which a drug is removed from the human system.\n\nIt is equivalent to the fraction of a substance that is removed per unit time measured at any particular instant and has units of 1/h.', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Vz/F for Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '549.0', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '526.0', 'spread': '1.69', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Vz/F=Apparent volume of distribution during terminal phase.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'MR AUC0-t and MR AUC0-inf for N-oxide Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'MR AUC0-t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.89', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '1.81', 'groupId': 'OG001'}]}]}, {'title': 'MR AUC0-inf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.38', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '5.74', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nArea under the serum concentration time curve from time 0 to time t (hours) (AUC0-t)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'MR Cmax for N-oxide Voriconazole - Part 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG001', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.40', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '1.54', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nCmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Bioavailability of Voriconazole - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG003', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'Parts 1, 2, and 3 - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '53.37', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '40.42', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '108.08', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '863.22', 'spread': '1.44', 'groupId': 'OG003'}]}]}, {'title': 'Part 2 - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57.11', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.13', 'ciLowerLimit': '0.107', 'ciUpperLimit': '0.146', 'groupDescription': 'Part 3 - ZP-059 20mg: Oral Voriconazole (200mg VFEND)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.10', 'ciLowerLimit': '1.545', 'ciUpperLimit': '2.853', 'groupDescription': 'ZP-059 20mg: Part 3 / Part 1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.63', 'ciLowerLimit': '1.953', 'ciUpperLimit': '3.544', 'groupDescription': 'ZP-059 20mg: Part 3 / Part 2 Day 1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.87', 'ciLowerLimit': '1.386', 'ciUpperLimit': '2.520', 'groupDescription': 'ZP-059 20mg: Part 3 / Part 2 Day 10', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 in Parts 1-3 and on Day 10 in Part 2', 'description': 'The Cmax estimated from Part 3 was analyzed to assess the relative bioavailability of inhaled ZP-059 to oral voriconazole.\n\nThe Cmax was compared between asthma subjects in Part 3 and healthy subjects in Part 1 and separately with asthma subjects in Part 2 to assess the relative bioavailability of ZP-059 dose taken in Part 3 in these populations.\n\nIn Part 1 and 3, Cmax was estimated only on Day1. In Part 2, Cmax was estimated on Day 10.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}, {'type': 'SECONDARY', 'title': 'Bioavailability of Voriconazole - AUC-inf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG001', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'OG002', 'title': 'Part 3 - ZP-059', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'OG003', 'title': 'Part 3 - Oral Voriconazole', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'classes': [{'title': 'Parts 1, 2, and 3 - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '203.96', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '155.72', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '269.61', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '3800.41', 'spread': '1.92', 'groupId': 'OG003'}]}]}, {'title': 'Part 2 - Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '258.66', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.07', 'ciLowerLimit': '0.059', 'ciUpperLimit': '0.075', 'groupDescription': 'Part 3 ZP-059 20mg: Oral Voriconazole (200mg VFEND®)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.27', 'ciLowerLimit': '0.850', 'ciUpperLimit': '1.891', 'groupDescription': 'ZP-059 20mg: Part 3 / Part 1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.63', 'ciLowerLimit': '1.953', 'ciUpperLimit': '3.544', 'groupDescription': 'ZP-059 20mg: Part 3 / Part 2 Day 1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.87', 'ciLowerLimit': '1.386', 'ciUpperLimit': '2.520', 'groupDescription': 'ZP-059 20mg: Part 3 / Part 2 Day 10', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 in Parts 1-3 and on Day 10 in Part 2', 'description': 'The AUC0-inf estimated from Part 3 was analyzed to assess the relative bioavailability of inhaled ZP-059 to oral voriconazole.\n\nThe AUC0-inf was compared between asthma subjects in Part 3 and healthy subjects in Part 1 and separately with asthma subjects in Part 2 to assess the relative bioavailability of ZP-059 dose taken in Part 3 in these populations.\n\nIn Part 1 and 3, AUC0-inf was estimated on Day 1. In part 2, AUC0-in f was estimated on Day 10.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Concentration Set: SAF subjects who had at least 1 quantifiable serum PK concentration recorded, analyzed according to the treatment actually taken.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'FG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'FG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'FG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'FG004', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'FG005', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'FG006', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) d) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'FG007', 'title': 'Part 3 - ZP-059 / Oral Voriconazole', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'FG008', 'title': 'Part 3 - Oral Voriconazole / ZP-059', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The investigator or his/her representative explained the nature of the study to the subject and answered all questions regarding the study. Subjects had to be informed that their participation was voluntary. Subjects were required to sign a statement of informed consent that met the requirements of UK regulations, ICH E6 GCP guidelines, General Data Protection Regulation, and the IEC or study site requirements.\n\nThe authorized person who obtained the informed consent had to also sign the ICF.', 'preAssignmentDetails': 'Subjects were screened for eligibility to participate in the study within 28 days before dosing (Day 1). Part 2 and Part 3 subjects who had completed the initial screening visit attended the study site on Day -4 or Day -3, for Covid-19 reverse transcriptase - polymerase chain reaction (RT-PCR) test, together with additional daily tympanic temperature measurements, and other tests as applicable.\n\nSubjects were then be admitted to the study site on the evening of Day -1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '58', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'BG001', 'title': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'BG002', 'title': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'BG003', 'title': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'BG004', 'title': 'Part 2 - ZP-059 10mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'BG005', 'title': 'Part 2 - ZP-059 20mg Bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'BG006', 'title': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) administered via DPI (RS01 monodose device) on Days 1 to 10.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).'}, {'id': 'BG007', 'title': 'Part 3 - ZP-059 / Oral Voriconazole', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'BG008', 'title': 'Part 3 - Oral Voriconazole / ZP-059', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.\n\nVoriconazole inhaled: Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a single inhaled dose (20mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).\n\noral voriconazole: Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '58', 'groupId': 'BG009'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '37', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '52', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '58', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Enrolled Set: subjects who passed screening irrespective of whether they received study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-04', 'size': 1522106, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-28T04:33', 'hasProtocol': True}, {'date': '2020-10-28', 'size': 291171, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-28T04:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Safety, tolerability and PK will be assessed following either single ascending (SAD) or multiple ascending (MAD) dosing of ZP-059; Part 1 and Part 2, respectively. Part 1 will comprise 4 separate cohorts planned to receive single doses of ZP-059; part 2 will comprise 3 separate cohorts planned to receive daily doses of ZP-059 on Day 1 to 10; part 3 is a 2-period, randomised crossover study in subjects with mild to moderate stable asthma to assess the safety, tolerability and PK of single doses of ZP-059 and single doses of oral voriconazole.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2019-12-06', 'resultsFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-12', 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAE)', 'timeFrame': 'Part 1: screening (Day -28 to -1) to follow-up (8 to 12 days after last dose); part 2: screening (Day -28 to -1) to follow-up (11-17 days after last dose); Part 3: screening (Day -28 to -1) to follow-up (8-12 days after last dose of study drug).', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of IMP, whether or not considered related to the study IMP.'}], 'secondaryOutcomes': [{'measure': 'AUC0-t, AUC0-inf for Voriconazole and N-oxide Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'AUC0-t = Area under the serum concentration time curve from time 0 to time t (hours) (AUC0-t) (AUC0-12 for Part 1) AUC0-inf = Area under the serum concentration time curve from time 0 to infinity'}, {'measure': 'Cmax for Voriconazole and N-oxide Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given;'}, {'measure': 'Tmax and T1/2 for Voriconazole and N-oxide Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Tmax= Time to maximum concentration (Cmax). T 1/2 = Elimination half-life: the time taken for the plasma concentration to fall by half its original value.'}, {'measure': 'Kel for Voriconazole and N-oxide Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Kel (Elimination rate constant): is a value used to describe the rate at which a drug is removed from the human system.\n\nIt is equivalent to the fraction of a substance that is removed per unit time measured at any particular instant and has units of 1/h.'}, {'measure': 'CL/F for Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Apparent clearance: Equal to the drug dose divided by the area-under-the-curve; is an important pharmacokinetic parameter and plays an important role in the selection of a safe and tolerable dose for first-in-human studies.'}, {'measure': 'Vz/F for Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'Vz/F=Apparent volume of distribution during terminal phase.'}, {'measure': 'MR AUC0-t, MR AUC0-inf for N-oxide Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nArea under the serum concentration time curve from time 0 to time t (hours) (AUC0-t)'}, {'measure': 'MR Cmax for N-oxide Voriconazole - Part 1', 'timeFrame': 'Part 1: at day 1 (pre-dose, at 1.5h-2h-3h-4h-12h post dose).', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nCmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.'}, {'measure': 'AUC0-t, AUC0-inf for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'AUC0-t = Area under the serum concentration time curve from time 0 to time t (hours) (AUC0-t) (AUC0-24 for Part 2) AUC0-inf = Area under the serum concentration time curve from time 0 to infinity'}, {'measure': 'Cmax for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given;'}, {'measure': 'Tmax and T1/2 for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Tmax= Time to maximum concentration (Cmax). T 1/2 = Elimination half-life: the time taken for the plasma concentration to fall by half its original value.'}, {'measure': 'Kel for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Kel (Elimination rate constant): is a value used to describe the rate at which a drug is removed from the human system.\n\nIt is equivalent to the fraction of a substance that is removed per unit time measured at any particular instant and has units of 1/h.'}, {'measure': 'CL/F for Voriconazole - Part 2', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Apparent clearance: Equal to the drug dose divided by the area-under-the-curve; is an important pharmacokinetic parameter and plays an important role in the selection of a safe and tolerable dose for first-in-human studies.'}, {'measure': 'Swing for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Swing for voriconazole and N-oxide voriconazole = \\[(Cmax - Cmin) / Cmin\\]\\*100%'}, {'measure': 'AUCtau for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Area under the serum concentration time curve for the dosing interval'}, {'measure': 'Css,av for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': "Css,av or Css(ave): Average drug concentration at steady state; Steady-state concentration (Css) occurs when the amount of a drug being absorbed is the same amount that's being cleared from the body when the drug is given continuously or repeatedly"}, {'measure': 'Fluctuation for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Peak trough fluctuation in serum concentrations within one dosing interval at steady state. Fluctuation - Over the Dosing Interval - is expressed as percentage concentration.'}, {'measure': 'Rac for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Accumulation ratio. The drug accumulation ratio (Rac) is the ratio of accumulation of a drug under steady state conditions as compared to a single dose. The higher the value, the more the drug accumulates in the body. An Rac of 1 means no accumulation.'}, {'measure': 'Rlinear for Voriconazole and N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Only at Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'Rlinear means linearity ratio for Area Under the Serum Concentration-Time Curve from time zero to infinity.'}, {'measure': 'MR AUC0-t, MR AUC0-inf and MR AUCtau for N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nArea under the serum concentration time curve from time 0 to time t (hours) (AUC0-t)'}, {'measure': 'MR Cmax N-oxide Voriconazole - Part 2', 'timeFrame': 'Part 2: Day 1 (1.5, 2, 3, 4, and 12 hours post-0-hour dose) and Day 10 (post-0-hour dose at 1.5, 2, 3, 4, and 12 hours)', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nCmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.'}, {'measure': 'Cmax for Voriconazole and N-oxide Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given;'}, {'measure': 'Vz/F for Voriconazole - Part 3', 'timeFrame': 'Only at Day 10', 'description': 'Vz/F=Apparent volume of distribution during terminal phase.'}, {'measure': 'AUC0-t, AUC0-inf for Voriconazole and N-oxide Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'AUC0-t = Area under the serum concentration time curve from time 0 to time t (hours) (AUC0-t) (AUC0-96 for Part 3) AUC0-inf = Area under the serum concentration time curve from time 0 to infinity'}, {'measure': 'Tmax and T1/2 for Voriconazole and N-oxide Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2 (Pre-dose, 0.25h, 0.75h 1.5h, 2h ,3h ,4h ,6h ,8h ,12h ,16h , 24h ,48h after dosing)', 'description': 'Tmax= Time to maximum concentration (Cmax). T 1/2 = Elimination half-life: the time taken for the plasma concentration to fall by half its original value.'}, {'measure': 'CL/F for Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Apparent clearance: Equal to the drug dose divided by the area-under-the-curve; is an important pharmacokinetic parameter and plays an important role in the selection of a safe and tolerable dose for first-in-human studies.'}, {'measure': 'Kel for Voriconazole and N-oxide Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Kel (Elimination rate constant): is a value used to describe the rate at which a drug is removed from the human system.\n\nIt is equivalent to the fraction of a substance that is removed per unit time measured at any particular instant and has units of 1/h.'}, {'measure': 'Vz/F for Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'Vz/F=Apparent volume of distribution during terminal phase.'}, {'measure': 'MR AUC0-t and MR AUC0-inf for N-oxide Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nArea under the serum concentration time curve from time 0 to time t (hours) (AUC0-t)'}, {'measure': 'MR Cmax for N-oxide Voriconazole - Part 3', 'timeFrame': 'Day 1 of the respective treatment period 1 or 2', 'description': 'MR = metabolite ratio. Metabolite ratios (as appropriate) will be calculated for AUC and Cmax parameters.\n\nCmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.'}, {'measure': 'Bioavailability of Voriconazole - Cmax', 'timeFrame': 'On Day 1 in Parts 1-3 and on Day 10 in Part 2', 'description': 'The Cmax estimated from Part 3 was analyzed to assess the relative bioavailability of inhaled ZP-059 to oral voriconazole.\n\nThe Cmax was compared between asthma subjects in Part 3 and healthy subjects in Part 1 and separately with asthma subjects in Part 2 to assess the relative bioavailability of ZP-059 dose taken in Part 3 in these populations.\n\nIn Part 1 and 3, Cmax was estimated only on Day1. In Part 2, Cmax was estimated on Day 10.'}, {'measure': 'Bioavailability of Voriconazole - AUC-inf', 'timeFrame': 'On Day 1 in Parts 1-3 and on Day 10 in Part 2', 'description': 'The AUC0-inf estimated from Part 3 was analyzed to assess the relative bioavailability of inhaled ZP-059 to oral voriconazole.\n\nThe AUC0-inf was compared between asthma subjects in Part 3 and healthy subjects in Part 1 and separately with asthma subjects in Part 2 to assess the relative bioavailability of ZP-059 dose taken in Part 3 in these populations.\n\nIn Part 1 and 3, AUC0-inf was estimated on Day 1. In part 2, AUC0-in f was estimated on Day 10.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABPA', 'Asthma', 'Voriconazole', 'Allergic Bronchopulmonary Aspergillosis'], 'conditions': ['Allergic Bronchopulmonary Aspergillosis']}, 'referencesModule': {'references': [{'pmid': '39918069', 'type': 'DERIVED', 'citation': 'Caponetti G, Sala F, Cervetti A, Colombo D, Tiberio E, Singh D. Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Inhaled Voriconazole in Healthy Volunteers and Subjects With Stable Asthma. Pharmacol Res Perspect. 2025 Feb;13(1):e70064. doi: 10.1002/prp2.70064.'}]}, 'descriptionModule': {'briefSummary': 'The primary safety objectives were:\n\n* Part 1: To determine the safety and tolerability of single doses of ZP-059 in healthy subjects\n* Part 2: To determine the safety and tolerability of multiple doses of ZP-059 in subjects with mild stable asthma\n* Part 3: To determine the safety and tolerability of single doses of ZP-059 in subjects with mild to moderate stable asthma.\n\nThe primary PK objectives were:\n\n* Part 1: To characterize systemic PK of voriconazole and N-oxide voriconazole after single doses of ZP-059 in healthy subjects\n* Part 2: To characterize systemic PK of voriconazole and N-oxide voriconazole after multiple doses of ZP-059 in subjects with mild stable asthma\n* Part 3: To characterize systemic PK of voriconazole and N-oxide voriconazole after single doses of ZP-059 and single doses of oral voriconazole in subjects with mild to moderate stable asthma.', 'detailedDescription': 'This was an integrated Phase 1, single centre, multi-part, open-label study in both healthy subjects (Part 1), subjects with mild stable asthma (Part 2) and subjects with mild to moderate stable asthma (Part 3). In all three parts of the study every effort was made to include as close as possible an equal balance between male and female subjects.\n\nThis study assessed safety, tolerability and PK of single and multiple ascending doses of ZP-059 capsules administered as dry powder for inhalation in Part 1 to healthy volunteers (single ascending dose; SAD) and in Part 2 to subjects with mild asthma (multiple ascending dose; MAD), respectively.\n\nIn Part 3, the bioavailability of ZP-059 in subjects with mild to moderate stable asthma were compared to that of oral voriconazole. Part 3 started only after review of safety data from cohorts 1 to 4 of Part 1 (SAD) have been completed. Parts 2 and 3 of the study also explored voriconazole concentrations in induced sputum samples in asthmatic subjects.\n\nAs part of the safety and tolerability assessment, this study investigated the effects of ZP-059 on airway function in both mild and mild to moderate stable asthma subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (part 1):\n\n* Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method\n* Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s)\n* Subject must agree not to donate semen or ova/oocytes during the study and for 14 days after the last dose of IMP.\n* BMI ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.\n* Are willing and able to comply with all aspects of the protocol.\n* FEV1 ≥80% of the predicted value and FEV1/FVC ratio \\> 0.70; at screening.\n* Able to demonstrate the correct inhalation technique for use of delivery device during the study at screening and pre-dose Day 1.\n\nInclusion Criteria (part 2):\n\n* Subjects with mild stable asthma with a documented physician confirmed diagnosis of asthma for at least 3 months prior to screening.\n* Asthma assessed by investigator as being stable for at least 4 weeks prior to screening and prior to Day 1.\n* Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method\n* Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s).\n* Subject must agree not to donate semen or ova/oocytes during the study and for 14 days after the last dose of IMP.\n* Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.\n* Are willing and able to comply with all aspects of the protocol.\n* Subject is being treated with short acting beta-agonists alone or in conjunction with low to medium doses of ICS.\n* Pre-bronchodilator FEV1 ≥70% of the predicted value at screening.\n* Able to demonstrate the correct inhalation technique for use of delivery device during the study at screening and pre-dose Day 1.\n\nInclusion Criteria (part 3):\n\n* Subjects with mild to moderate stable asthma with a documented physician confirmed diagnosis of asthma for at least 3 months prior to screening.\n* Asthma assessed by investigator as being stable for at least 4 weeks prior to screening and prior to randomisation.\n* Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method .\n* Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s)\n* Subject must agree not to donate semen or ova/oocytes during the study and for 14 days after the last dose of IMP.\n* BMI ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.\n* Are willing and able to comply with all aspects of the protocol.\n* Subject is being treated with low to medium doses of ICS with or without long-acting beta-agonists.\n* Pre-bronchodilator FEV1 ≥70% of the predicted value at screening.\n* Able to demonstrate the correct inhalation technique for use of delivery device during the study at screening and pre-dose Day 1, Treatment Period 1.\n* Able to produce a sputum sample with a minimum weight of 50 mg at screening.\n\nExclusion Criteria (part 1):\n\n* Subjects who are Chinese or Japanese.\n* Subjects who have received any IMP in a clinical research study within the previous 3 months prior to Day 1.\n* Participation in other interventional studies for the duration of the study.\n* Subjects who are study site employees or immediate family members of a study site or sponsor employee.\n* History of any drug or alcohol abuse in the past 2 years prior to screening.\n* Regular alcohol consumption in males \\>21 units per week and females \\>14 units per week (1 unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine depending on type).\n* Current tobacco or marijuana smokers and those who have smoked within the last 12 months prior to screening or prior to Day 1.\n* A confirmed positive urine cotinine test at screening or Day -1.\n* Current users of e-cigarettes or nicotine replacement products and those who have used these products within the last 12 months prior to screening or prior to Day 1.\n* Smoking history of \\>5 pack years at screening.\n* Females of childbearing potential who are pregnant or lactating, or who plan to become pregnant during the study. A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or is postmenopausal (had no menses for 12 months without an alternative medical cause).\n* Female subject with a positive pregnancy test at screening or pre-dose on Day 1.\n* Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.\n* Evidence or history of clinically significant abnormal biochemistry, haematology or urinalysis at screening, as judged by the investigator; the investigator should contact the medical monitor and /or the sponsor if required.\n* Positive urine drugs of abuse test or alcohol breath test result at screening or Day -1.\n* History of or currently infected with/carrier of human immunodeficiency virus (HIV).\n* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results. Subjects who are HBs antibody positive or HB core antibody positive are not excluded provided the HBsAg result is negative. Subjects who are HCV Ab positive are not excluded if a subsequent HCV RNA test is negative.\n* Evidence or history of clinically significant cardiovascular, renal, hepatic, endocrine, immunological or autoimmune, dermatological, ophthalmological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.\n* Subjects with congestive heart failure or a history of congestive heart failure.\n* 12-lead ECGs demonstrating a mean QTcF interval \\>450 msec for males or QTcF interval \\>470 msec for females at screening or pre-dose Day 1.\n* History of severe cough or bronchospasm upon inhalation of any inhalation product.\n* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.\n* Have had allergies to or hypersensitivity reactions after administration of voriconazole or other antifungal azoles.\n* Presence or history of clinically significant allergy, including drug allergies, but excluding untreated, mild seasonal allergies, as judged by the investigator. Hay fever is allowed unless it is active.\n* Major trauma or surgery within the last 3 months prior to screening or prior to Day 1.\n* Planned or elective surgery or hospitalisations for the duration of the study that may interfere with study logistics or safety.\n* Donation or loss of more than 400 mL of blood within the previous 3 months prior to screening.\n* Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than ≤4 g per day of paracetamol, hormonal contraception or hormone replacement therapy), dietary supplements or CYP3A4 or CYP2C19 inhibitors in the 14 days (or 5 half-lives, whichever is longer) prior to Day 1 and for the duration of the study. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the Principal Investigator and sponsor's medical monitor.\n* Subjects who are taking or have taken any herbal remedies or CYP3A4 or CYP2C19 inducers in the 28 days prior to Day 1.\n* Any use of voriconazole in the 3 months prior to Day 1.\n* Subjects who have received a live or killed/inactive vaccine in the 14 days prior to Day 1.\n* Upper respiratory tract infection (excluding otitis media), fever, acute or chronic cough within 14 days of Day 1, or lower respiratory tract infection within the last 4 weeks prior to Day 1.\n* Recent (within the last 4 weeks prior to Day 1) clinically significant bacterial, viral or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals or antifungals; topical treatments, other than antifungals, are allowed.\n* Other social, psychiatric, surgical or medical conditions, or screening laboratory abnormalities that may increase subject risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator would make the subject inappropriate for entry into the study.\n* Failure to satisfy the investigator of fitness to participate for any reason.\n\nExclusion Criteria (part 2 and 3):\n\n* Subjects who are Chinese or Japanese.\n* Subjects who have received any IMP in a clinical research study within the previous 3 months prior to Day 1.\n* Participation in other interventional studies for the duration of the study.\n* Subjects who are study site employees, or immediate family members of a study site or sponsor employee.\n* Subjects who have previously received IMP in this study.\n* History of any drug or alcohol abuse in the past 2 years prior to screening.\n* Regular alcohol consumption in males \\>21 units per week and females \\>14 units per week (1 unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine depending on type).\n* Current tobacco or marijuana smokers and those who have smoked within the last 12 months prior to screening or prior to Day 1.\n* A confirmed positive urine cotinine test at screening or Day -1.\n* Current users of e-cigarettes or nicotine replacement products and those who have used these products within the last 12 months prior to screening or prior to Day 1.\n* Smoking history of \\>5 pack years at screening.\n* Females of childbearing potential who are pregnant or lactating, or who plan to become pregnant during the study. A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or is postmenopausal (had no menses for 12 months without an alternative medical cause).\n* Female subject with a positive pregnancy test at screening or pre-dose Day 1.\n* Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.\n* Evidence or history of clinically significant abnormal biochemistry, haematology or urinalysis at screening, as judged by the investigator; the investigator should contact the medical monitor and /or the sponsor if required.\n* Positive urine drugs of abuse test result (unless in the opinion of the investigator this can be explained by the subject's current medications) at screening or Day -1; unexpected positive results may require discussion with sponsor).\n* Positive alcohol breath test at screening or Day -1.\n* History of or currently infected with/carrier of HIV.\n* Positive HBsAg, HCV Ab or HIV results. Subjects who are HBs antibody positive or HB core antibody positive are not excluded provided the HBsAg result is negative. Subjects who are HCV Ab positive are not excluded if a subsequent HCV RNA test is negative.\n* Evidence or history of clinically significant cardiovascular, renal, hepatic, dermatologic, ophthalmologic or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.\n* Evidence of history of endocrine, immunological, autoimmune disease that would affect the subject's safety or confound the assessment of study endpoints in the opinion of the investigator.\n* Current diagnosis of any chronic airways disease other than asthma such as Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, CF, Churg-Strauss syndrome, bronchiectasis.\n* Evidence of ventricular dysfunction such as congestive cardiac failure (CCF) or a history of CCF assessed at screening and pre-dose Day 1.\n* 12-lead ECG demonstrating a mean QTcF interval \\>450 msec for males or \\>470 msec for females at screening or pre-dose Day 1.\n* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.\n* Have had allergies to or hypersensitivity reactions after administration of voriconazole or other antifungal azoles.\n* Presence or history of clinically significant allergy, including drug allergies, as judged by the investigator. Hay fever is allowed unless it is active.\n* Major trauma or surgery within the last 3 months prior to screening or prior to Day 1.\n* Planned or elective surgery, hospitalisations for the duration of the study that may interfere with study logistics or safety.\n* Donation or loss of more than 400 mL of blood within the previous 3 months prior to screening.\n* Subjects who are taking, or have taken, any prescribed or over-the-counter drugs that are CYP3A4 or CYP2C19 inhibitors in the 14 days (or 5 half-lives, whichever is longer) prior to Day 1 and for the duration of the study.\n* Subjects who are taking or have taken any herbal remedies or CYP3A4 or CYP2C19 inducers in the 28 days prior to Day 1.\n* Subjects who have received a live or killed/inactive vaccine in the 14 days prior to Day 1.\n* Presence of hoarseness or oropharyngeal candidiasis at screening or prior to dosing on Day 1.\n* Any use of voriconazole in the 3 months prior to Day 1.\n* History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures.\n* Hospitalisation (including accident and emergency visits) for the treatment of asthma within 3 months prior to screening or prior to Day 1 or have been hospitalised or have attended the accident and emergency for asthma more than twice in the 12 months prior to screening.\n* Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening or prior to Day 1.\n* Recent (within the last 4 weeks prior to Day 1) clinically significant bacterial, viral or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals or antifungals; topical treatments, other than antifungals, are allowed.\n* Other social, psychiatric, surgical or medical conditions, or screening laboratory abnormalities that may increase subject risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the Investigator would make the subject inappropriate for entry into the study.\n* Failure to satisfy the investigator of fitness to participate for any reason."}, 'identificationModule': {'nctId': 'NCT04229303', 'briefTitle': 'Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zambon SpA'}, 'officialTitle': 'To Assess Safety, PK of Inhaled Voriconazole (ZP-059) Single Doses in Healthy Subjects (Part 1), ZP-059 Multiple Doses in Stable Asthma (Part 2) and in a Crossover Trial of ZP-059 and Oral Voriconazole Single Doses in Stable Asthma (Part 3)', 'orgStudyIdInfo': {'id': 'Z7240J01'}, 'secondaryIdInfos': [{'id': '2019-004031-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - ZP-059 5mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 1: 5mg (1 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.', 'interventionNames': ['Drug: Voriconazole inhaled']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 - ZP-059 10mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 2: 10mg (2 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.', 'interventionNames': ['Drug: Voriconazole inhaled']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 - ZP-059 20mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 3: 20mg (4 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.', 'interventionNames': ['Drug: Voriconazole inhaled']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 - ZP-059 40mg', 'description': 'Part 1: administration of single ascending doses (SAD) of ZP-059.\n\nCohort 4: 40mg (8 x 5 mg capsule) ZP-059 single dose administered via DPI (RS01 monodose device) on Day 1.', 'interventionNames': ['Drug: Voriconazole inhaled']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - ZP-059 10mg bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Days 1 to 10.\n\nCohort 1: 10mg (2 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.', 'interventionNames': ['Drug: Voriconazole inhaled']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - ZP-059 20mg bid', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 2: 20mg (4 x 5 mg capsule) ZP-059 twice daily (bid) administered via DPI (RS01 monodose device) for 9 days and once in the morning of Day 10.', 'interventionNames': ['Drug: Voriconazole inhaled']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - ZP-059 40mg qd', 'description': 'Part 2: administration of multiple ascending doses (MAD) of ZP-059 on Day 1 to 10.\n\nCohort 3: 40mg (8 x 5 mg capsule) ZP-059 once daily (qd) administered via DPI (RS01 monodose device) on Days 1 to 10.', 'interventionNames': ['Drug: Voriconazole inhaled']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 - ZP-059 / Oral Voriconazole', 'description': 'Crossover treatment period: Single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI, and a single dose of oral voriconazole (200 mg Vfend® tablet) on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.', 'interventionNames': ['Drug: Voriconazole inhaled', 'Drug: oral voriconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 - Oral Voriconazole / ZP-059', 'description': 'Crossover treatment period: Single dose of oral voriconazole (200 mg Vfend® tablet), and a single inhaled dose (20 mg) of ZP-059 5mg capsules administered via DPI on the morning of Day 1 of the respective treatment period with a washout period of at least 96 hours.', 'interventionNames': ['Drug: Voriconazole inhaled', 'Drug: oral voriconazole']}], 'interventions': [{'name': 'Voriconazole inhaled', 'type': 'DRUG', 'otherNames': ['ZP-059'], 'description': 'Part 1 (SAD): eligible subjects received a single ascending inhaled dose (5 mg, 10 mg, 20 mg, and 40 mg) of ZP-059 5mg capsules administered via dry powder inhaler (DPI) on the morning of Day 1.\n\nPart 2 (MAD): eligible subjects received 2 (10mg twice daily \\[BID\\]) or 4 \\[20mg BID\\]) inhaled doses of ZP-059 5mg capsules administered via DPI BID for 9 days and once in the morning of Day 10, or 8 inhaled doses of ZP-059 5 mg capsules (40mg once daily \\[QD\\]) for 10 days. For QD dosing, subjects received QD doses of ZP-059 (at hour 0) on Days 1 to 10.\n\nPart 3 (2-period crossover): eligible subjects received a 4 \\[20mg BID\\] inhaled doses of ZP-059 5mg capsules administered via DPI on the morning of Day 1 according to the crossover scheme of the study.\n\nZP-059 (inhaled voriconazole) was provided in clear, colorless size 3 hydroxypropylmethylcellulose hard capsules, which were individually and manually triggered by a breath actuated inhalation device (RS01 monodose inhaler).', 'armGroupLabels': ['Part 1 - ZP-059 10mg', 'Part 1 - ZP-059 20mg', 'Part 1 - ZP-059 40mg', 'Part 1 - ZP-059 5mg', 'Part 2 - ZP-059 10mg bid', 'Part 2 - ZP-059 20mg bid', 'Part 2 - ZP-059 40mg qd', 'Part 3 - Oral Voriconazole / ZP-059', 'Part 3 - ZP-059 / Oral Voriconazole']}, {'name': 'oral voriconazole', 'type': 'DRUG', 'otherNames': ['Vfend'], 'description': 'Part 3 (2-period crossover): eligible subjects received a single dose of oral voriconazole (200mg oral film-coated tablet, Vfend) on the morning of Day 1 according to the crossover scheme of the study.', 'armGroupLabels': ['Part 3 - Oral Voriconazole / ZP-059', 'Part 3 - ZP-059 / Oral Voriconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M239QZ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Medicines Evaluation Unit Ltd. (MEU)', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sukh Dave Singh, Prof, MD,', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Medicine Evaluation Unit (MEU) Ltd, Langley building,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zambon SpA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}