Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-03 @ 6:40 AM
Study NCT ID:
NCT03075267
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2017-03-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Pearl Therapeutics, Inc.', 'organization': 'Pearl Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': "The study site will have the opportunity to publish the results of the study, provided that the sponsor has had the opportunity to review and comment on the study site's proposed publication prior to its being submitted for publication with the prior advice of legal (intellectual property counsel) and with proper regard to the protection of subjects' identities.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.', 'description': 'The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.', 'eventGroups': [{'id': 'EG000', 'title': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 14, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PT010 (BGF MDI) 160/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 11, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PT003 (GFF MDI) 14.4/9.6 µg', 'description': 'PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 14, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) - Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg'}, {'id': 'OG001', 'title': 'PT010 (BGF MDI) 160/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '459.308', 'spread': '67.6', 'groupId': 'OG000'}, {'value': '224.298', 'spread': '98.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Budesonide Day 1', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) - Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'description': 'PT010 Budesonide, 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parameter and did not have a major protocol deviation'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) - Formoterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg'}, {'id': 'OG001', 'title': 'PT010 (BGF MDI) 160/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg'}, {'id': 'OG002', 'title': 'PT003 (GFF MDI) 14.4/9.6 µg', 'description': 'PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '9.651', 'spread': '55.8', 'groupId': 'OG000'}, {'value': '9.932', 'spread': '71.9', 'groupId': 'OG001'}, {'value': '10.618', 'spread': '76.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Formoterol Day 1', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) - Formoterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler 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'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg'}, {'id': 'OG001', 'title': 'PT010 (BGF MDI) 160/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg'}, {'id': 'OG002', 'title': 'PT003 (GFF MDI) 14.4/9.6 µg', 'description': 'PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg'}], 'classes': [{'categories': [{'measurements': [{'value': '29.400', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '27.197', 'spread': '41.3', 'groupId': 'OG001'}, {'value': '29.002', 'spread': '42.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1', 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'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '59.99', 'spread': '5.29', 'groupId': 'BG000'}, {'value': '60.00', 'spread': '6.13', 'groupId': 'BG001'}, {'value': '62.75', 'spread': '5.31', 'groupId': 'BG002'}, {'value': '60.91', 'spread': '5.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '21.6', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '21.9', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '21.7', 'spread': '1.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Demographics', 'populationDescription': 'Safety Population - all subjects who received at least 1 dose of any blinded study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-24', 'size': 1169355, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-03T09:50', 'hasProtocol': False}, {'date': '2017-05-12', 'size': 1955026, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-23T03:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2017-03-06', 'resultsFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-23', 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Budesonide Day 1'}, {'measure': 'Maximum Plasma Concentration (Cmax) - Budesonide', 'timeFrame': 'Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Budesonide Day 8'}, {'measure': 'Maximum Plasma Concentration (Cmax) - Glycopyrronium', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Glycopyrronium Day 1'}, {'measure': 'Maximum Plasma Concentration (Cmax) - Glycopyrronium', 'timeFrame': 'Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Glycopyrronium Day 8'}, {'measure': 'Maximum Plasma Concentration (Cmax) - Formoterol', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Formoterol Day 1'}, {'measure': 'Maximum Plasma Concentration (Cmax) - Formoterol', 'timeFrame': 'Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Maximum plasma concentration (Cmax) of Formoterol Day 8'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide', 'timeFrame': 'Day 8', 'description': 'Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium', 'timeFrame': 'Day 8', 'description': 'Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol', 'timeFrame': 'Day 8', 'description': 'Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Time to maximum plasma concentration (tmax) - Budesonide Day 1'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) - Budesonide', 'timeFrame': 'Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Time to maximum plasma concentration (tmax) - Budesonide Day 8'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium', 'timeFrame': 'Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) - Formoterol', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Time to maximum plasma concentration (tmax) - Formoterol Day 1'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) - Formoterol', 'timeFrame': 'Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Time to maximum plasma concentration (tmax) - Formoterol Day 8'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol', 'timeFrame': 'Day 1', 'description': 'Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1'}, {'measure': 'Elimination Half-life (t½) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Elimination half-life (t½) - Budesonide Day 1'}, {'measure': 'Elimination Half-life (t½) - Glycopyrronium', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Elimination half-life (t½) - Glycopyrronium Day 1'}, {'measure': 'Elimination Half-life (t½) - Formoterol', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Elimination half-life (t½) - Formoterol Day 1'}, {'measure': 'Apparent Total Body Clearance (CL/F) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Apparent total body clearance (CL/F) - Budesonide Day 1'}, {'measure': 'Apparent Total Body Clearance (CL/F) - Glycopyrronium', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Apparent total body clearance (CL/F) - Glycopyrronium Day 1'}, {'measure': 'Apparent Total Body Clearance (CL/F) - Formoterol', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Apparent total body clearance (CL/F) - Formoterol Day 1'}, {'measure': 'Apparent Volume of Distribution (Vd/F) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Apparent volume of distribution (Vd/F) - Budesonide - Day 1'}, {'measure': 'Apparent Volume of Distribution (Vd/F) - Glycopyrronium', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1'}, {'measure': 'Apparent Volume of Distribution (Vd/F) - Formoterol', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Apparent volume of distribution (Vd/F) - Formoterol - Day 1'}, {'measure': 'Terminal Elimination Rate Constant (λz) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Terminal elimination rate constant (λz) - Budesonide - Day 1'}, {'measure': 'Terminal Elimination Rate Constant (λz) - Glycopyrronium', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Terminal elimination rate constant (λz) - Glycopyrronium - Day 1'}, {'measure': 'Terminal Elimination Rate Constant (λz) - Formoterol', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Terminal elimination rate constant (λz) - Formoterol - Day 1'}, {'measure': 'Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Accumulation ratio for Cmax (RAC \\[Cmax\\]) - Budesonide'}, {'measure': 'Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium', 'timeFrame': 'Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose', 'description': 'Accumulation ratio for Cmax (RAC \\[Cmax\\]) - Glycopyrronium'}, {'measure': 'Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol', 'timeFrame': 'Day 1 and Day 8', 'description': 'Accumulation ratio for Cmax (RAC \\[Cmax\\]) - Formoterol'}, {'measure': 'Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide', 'timeFrame': 'Day 1 and Day 8', 'description': 'Accumulation ratio for AUC 0-12 (RAC \\[AUC 0-12\\]) - Budesonide'}, {'measure': 'Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium', 'timeFrame': 'Day 1 and Day 8', 'description': 'Accumulation ratio for AUC 0-12 (RAC \\[AUC 0-12\\]) - Glycopyrronium'}, {'measure': 'Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol', 'timeFrame': 'Day 1 and Day 8', 'description': 'Accumulation ratio for AUC 0-12 (RAC \\[AUC 0-12\\]) - Formoterol'}], 'secondaryOutcomes': [{'measure': 'Physical Exam Findings', 'timeFrame': 'Visit 4, Day 8', 'description': 'Number of subjects with clinically significant changes in post baseline physical exam findings'}, {'measure': 'Laboratory Tests', 'timeFrame': 'Visit 4, Day 8', 'description': 'Number of subjects with clinically significant changes in post baseline laboratory tests'}, {'measure': 'Electrocardiogram', 'timeFrame': 'Visit 4, Day 8', 'description': 'Number of subjects with clinically significant changes in post baseline electrocardiogram'}, {'measure': 'Serious Adverse Events/Adverse Events', 'timeFrame': 'Visit 4, Day 8', 'description': 'Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal'}, {'measure': 'Vital Signs', 'timeFrame': 'Visit 4, Day 8', 'description': 'Number of subjects with clinically significant changes in post baseline vital signs'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '33152467', 'type': 'DERIVED', 'citation': 'Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.'}, {'pmid': '30982547', 'type': 'DERIVED', 'citation': 'Chen Q, Hu C, Yu H, Shen K, Assam PN, Gillen M, Liu Y, Dorinsky P. Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study. Clin Ther. 2019 May;41(5):897-909.e1. doi: 10.1016/j.clinthera.2019.03.007. Epub 2019 Apr 11.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=PT010010&attachmentIdentifier=655b9508-3a4c-48cb-835e-ad569131ecb6&fileName=PT010010-03_China_PK_CSP_v4.0_Redacted-PDF-A.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=PT010010&attachmentIdentifier=aff556d3-330c-4fa8-af1a-1fd3f266eb35&fileName=PT010010_SAP_v1.0_2017-08-24_Redacted-PDF-A.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects', 'detailedDescription': 'A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female Chinese subjects 18-45 years of age\n* Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.\n\nA male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception\n\n-Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.\n\nExclusion Criteria:\n\n* Pregnant or nursing female subjects or subjects who are trying to conceive\n* Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study\n* Subjects with a history of ECG abnormalities\n* Subjects who have cancer that has not been in complete remission for at least 5 years\n* Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator\n* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening\n* Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator\n* Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated\n* History of substance-related disorders within 1 year of Screening\n* History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting\n* A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period\n* Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days\n* Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening\n* Positive for Syphilis Antibody\n* Subjects with any flu-like syndrome or other respiratory infections\n* Recently vaccinated with an attenuated live virus'}, 'identificationModule': {'nctId': 'NCT03075267', 'briefTitle': 'Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days', 'orgStudyIdInfo': {'id': 'PT010010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'description': 'PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg', 'interventionNames': ['Drug: PT010 (BGF MDI) 320/14.4/9.6 µg']}, {'type': 'EXPERIMENTAL', 'label': 'PT010 (BGF MDI) 160/14.4/9.6 µg', 'description': 'PT010 (BGF MDI) 160/14.4/9.6 µg', 'interventionNames': ['Drug: PT010 (BGF MDI) 160/14.4/9.6 µg']}, {'type': 'EXPERIMENTAL', 'label': 'PT003 (GFF MDI) 14.4/9.6 µg', 'description': 'PT003 (GFF MDI) 14.4/9.6 µg', 'interventionNames': ['Drug: PT003 (GFF MDI) 14.4/9.6 µg']}], 'interventions': [{'name': 'PT010 (BGF MDI) 320/14.4/9.6 µg', 'type': 'DRUG', 'otherNames': ['Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler'], 'description': 'A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.', 'armGroupLabels': ['PT010 (BGF MDI) 320/14.4/9.6 µg']}, {'name': 'PT010 (BGF MDI) 160/14.4/9.6 µg', 'type': 'DRUG', 'otherNames': ['Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler'], 'description': 'A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.', 'armGroupLabels': ['PT010 (BGF MDI) 160/14.4/9.6 µg']}, {'name': 'PT003 (GFF MDI) 14.4/9.6 µg', 'type': 'DRUG', 'otherNames': ['Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler'], 'description': 'A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.', 'armGroupLabels': ['PT003 (GFF MDI) 14.4/9.6 µg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Paul M. Dorinsky, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pearl Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pearl Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}