Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
Study NCT ID:
NCT03971695
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2019-05-31
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': "Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days.", 'description': 'Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.', 'eventGroups': [{'id': 'EG000', 'title': 'Part I - Placebo Oral Solution', 'description': 'Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part I - Placebo Capsules', 'description': 'Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part I - 0.3 mg BI 706321 Oral Solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part I - 0.6 mg BI 706321 Oral Solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part I - 1.2 mg BI 706321 Oral Solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part I - 2 mg BI 706321 Capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part I - 4 mg BI 706321 Capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part I - 8 mg BI 706321 Capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part I - 15 mg BI 706321 Capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part I - 25 mg BI 706321 Capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part II - Test 1 (T1), Fasted, Tablets', 'description': 'Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Part II - Test 2 (T2), Fed, Tablets', 'description': 'Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Part II - Reference (R), Fasted, Capsules', 'description': 'Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Placebo Total', 'description': 'All subjects treated with placebo oral solution or placebo capsules groups.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'BI 706321 Total Part I', 'description': 'All subjects in Part I treated with BI 706321.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 15, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Total Part I', 'description': 'All subjects in Part I.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 21, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'BI 706321 Total Part II', 'description': 'All subjects in Part II treated with BI 706321.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'BI 706321 Total', 'description': 'All subjects in Part I and II treated with BI 706321.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 19, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG018', 'title': 'Total', 'description': 'All subjects in Part I and II.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 25, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Photokeratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pre-existing condition improved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Puncture site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part I: Percentage of Subjects With Drug-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I - Placebo Oral Solution', 'description': 'Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.'}, {'id': 'OG001', 'title': 'Part I - 0.3 mg BI 706321 Oral Solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Part I - 0.6 mg BI 706321 Oral Solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Part I - 1.2 mg BI 706321 Oral Solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Part I - Placebo Capsules', 'description': 'Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.'}, {'id': 'OG005', 'title': 'Part I - 2 mg BI 706321 Capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Part I - 4 mg BI 706321 Capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Part I - 8 mg BI 706321 Capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG008', 'title': 'Part I - 15 mg BI 706321 Capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG009', 'title': 'Part I - 25 mg BI 706321 Capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '11.1', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '16.7', 'groupId': 'OG007'}, {'value': '20.0', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Between intake of trial medication and the individual subject's end of trial, up to 22 days.", 'description': 'Part I: Percentage of subjects with drug-related adverse events.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.'}, {'type': 'PRIMARY', 'title': 'Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II - Test 1 (T1), Fasted, Tablets', 'description': 'Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Part II - Test 2 (T2), Fed, Tablets', 'description': 'Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast.'}, {'id': 'OG002', 'title': 'Part II - Reference (R), Fasted, Capsules', 'description': 'Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '138', 'spread': '29.9', 'groupId': 'OG001'}, {'value': '150', 'spread': '29.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted geometric mean (gMean) ratio(%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.26', 'ciLowerLimit': '90.18', 'ciUpperLimit': '111.48', 'estimateComment': 'Intra-individual geometric coefficient of variance (gCV) = 14.2. Ratio is T1/R.', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.", 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean (gMean) ratio(%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.63', 'ciLowerLimit': '85.37', 'ciUpperLimit': '98.35', 'estimateComment': 'Intra-individual geometric coefficient of variance (gCV) = 9.5. Ratio is T2/T1.', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.", 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.', 'description': 'Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).', 'unitOfMeasure': 'hour*nanomol/liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK.'}, {'type': 'PRIMARY', 'title': 'Part II: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II - Test 1 (T1), Fasted, Tablets', 'description': 'Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Part II - Test 2 (T2), Fed, Tablets', 'description': 'Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast.'}, {'id': 'OG002', 'title': 'Part II - Reference (R), Fasted, Capsules', 'description': 'Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.90', 'spread': '47.8', 'groupId': 'OG000'}, {'value': '4.57', 'spread': '33.6', 'groupId': 'OG001'}, {'value': '6.02', 'spread': '41.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted geometric mean (gMean) ratio(%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.01', 'ciLowerLimit': '84.20', 'ciUpperLimit': '114.08', 'estimateComment': 'Intra-individual geometric coefficient of variance (gCV) = 20.5. Ratio is T1/R.', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.", 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean (gMean) ratio(%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '77.52', 'ciLowerLimit': '68.11', 'ciUpperLimit': '88.22', 'estimateComment': 'Intra-individual geometric coefficient of variance (gCV) = 17.4. Ratio is T2/T1.', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.", 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.', 'description': 'Part II: Maximum measured concentration of BI 706321 in plasma (Cmax).', 'unitOfMeasure': 'nanomol/liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK.'}, {'type': 'SECONDARY', 'title': 'Part I: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I - 0.3 mg BI 706321 Oral Solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Part I - 0.6 mg BI 706321 Oral Solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Part I - 1.2 mg BI 706321 Oral Solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Part I - 2 mg BI 706321 Capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Part I - 4 mg BI 706321 Capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Part I - 8 mg BI 706321 Capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Part I - 15 mg BI 706321 Capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Part I - 25 mg BI 706321 Capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient concentration data above the lower limit of assay quantitation', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient concentration data above the lower limit of assay quantitation', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient concentration data above the lower limit of assay quantitation', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient concentration data above the lower limit of assay quantitation', 'groupId': 'OG003'}, {'value': '151', 'spread': '33.1', 'groupId': 'OG004'}, {'value': '314', 'spread': '25.7', 'groupId': 'OG005'}, {'value': '618', 'spread': '36.1', 'groupId': 'OG006'}, {'value': '1130', 'spread': '24.2', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.', 'description': 'Part I: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).', 'unitOfMeasure': 'hour*nanomol/liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK.'}, {'type': 'SECONDARY', 'title': 'Part I: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I - 0.3 mg BI 706321 Oral Solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Part I - 0.6 mg BI 706321 Oral Solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Part I - 1.2 mg BI 706321 Oral Solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Part I - 2 mg BI 706321 Capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Part I - 4 mg BI 706321 Capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Part I - 8 mg BI 706321 Capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Part I - 15 mg BI 706321 Capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Part I - 25 mg BI 706321 Capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.388', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '0.781', 'spread': '21.4', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '40.0', 'groupId': 'OG002'}, {'value': '2.27', 'spread': '30.1', 'groupId': 'OG003'}, {'value': '5.19', 'spread': '38.6', 'groupId': 'OG004'}, {'value': '11.8', 'spread': '41.6', 'groupId': 'OG005'}, {'value': '24.6', 'spread': '43.0', 'groupId': 'OG006'}, {'value': '41.1', 'spread': '32.1', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.', 'description': 'Part I: Maximum measured concentration of BI 706321 in plasma (Cmax).', 'unitOfMeasure': 'nanomol/liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK.'}, {'type': 'SECONDARY', 'title': 'Part I: Time From Dosing to the Maximum Measured Concentration of BI 706321 in Plasma (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I - 0.3 mg BI 706321 Oral Solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Part I - 0.6 mg BI 706321 Oral Solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Part I - 1.2 mg BI 706321 Oral Solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Part I - 2 mg BI 706321 Capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Part I - 4 mg BI 706321 Capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Part I - 8 mg BI 706321 Capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Part I - 15 mg BI 706321 Capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Part I - 25 mg BI 706321 Capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.61', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '5.25', 'spread': '51.6', 'groupId': 'OG001'}, {'value': '5.22', 'spread': '31.8', 'groupId': 'OG002'}, {'value': '5.24', 'spread': '51.6', 'groupId': 'OG003'}, {'value': '4.91', 'spread': '22.3', 'groupId': 'OG004'}, {'value': '4.12', 'spread': '43.7', 'groupId': 'OG005'}, {'value': '3.37', 'spread': '70.7', 'groupId': 'OG006'}, {'value': '3.64', 'spread': '62.1', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.', 'description': 'Part I: Time from dosing to the maximum measured concentration of BI 706321 in plasma (tmax).', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK.'}, {'type': 'SECONDARY', 'title': 'Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part II - Test 1 (T1), Fasted, Tablets', 'description': 'Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Part II - Test 2 (T2), Fed, Tablets', 'description': 'Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast.'}, {'id': 'OG002', 'title': 'Part II - Reference (R), Fasted, Capsules', 'description': 'Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '154', 'spread': '28.0', 'groupId': 'OG001'}, {'value': '171', 'spread': '27.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted geometric mean (gMean) ratio(%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.42', 'ciLowerLimit': '86.96', 'ciUpperLimit': '106.90', 'estimateComment': 'Intra-individual geometric coefficient of variance (gCV) = 13.9. Ratio is T1/R.', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.", 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean (gMean) ratio(%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.27', 'ciLowerLimit': '85.40', 'ciUpperLimit': '97.54', 'estimateComment': 'Intra-individual geometric coefficient of variance (gCV) = 8.9. Ratio is T2/T1.', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.", 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.', 'description': 'Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).', 'unitOfMeasure': 'hour*nanomol/liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part I - Placebo Oral Solution', 'description': 'Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.'}, {'id': 'FG001', 'title': 'Part I - 0.3 mg BI 706321 Oral Solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG002', 'title': 'Part I - 0.6 mg BI 706321 Oral Solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG003', 'title': 'Part I - 1.2 mg BI 706321 Oral Solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG004', 'title': 'Part I - Placebo Capsules', 'description': 'Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.'}, {'id': 'FG005', 'title': 'Part I - 2 mg BI 706321 Capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG006', 'title': 'Part I - 4 mg BI 706321 Capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG007', 'title': 'Part I - 8 mg BI 706321 Capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG008', 'title': 'Part I - 15 mg BI 706321 Capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG009', 'title': 'Part I - 25 mg BI 706321 Capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'FG010', 'title': 'Part II - R-T1-T2', 'description': 'Part II - R-T1-T2 - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Treatments in Part II were separated by a washout period of at least 12 days.'}, {'id': 'FG011', 'title': 'Part II - T1-T2-R', 'description': 'Part II - T1-T2-R - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.'}, {'id': 'FG012', 'title': 'Part II - T2-R-T1', 'description': 'Part II - T2-R-T1 - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.'}], 'periods': [{'title': 'Part I and Period 1 of Part II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'End of Part I and Part II - Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG008', 'numSubjects': '0'}, {'comment': 'Participants did not take part in the crossover part (Part II) of the study.', 'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not participate in part II of study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part II - Period 2', 'milestones': [{'type': 'STARTED', '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part II - Washout (of at Least 12 Days)', 'milestones': [{'type': 'STARTED', '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part II - Period 3', 'milestones': [{'type': 'STARTED', '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Part I of the trial was designed as randomised, placebo-controlled, and single-blind, within parallel dose groups.\n\nPart II of the trial was designed as a randomised, open-label, 3-way crossover to compare the treatments T1 and R (comparison A) and T2 and T1 (comparison B).', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '73', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Part I - Placebo Oral Solution', 'description': 'Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.'}, {'id': 'BG001', 'title': 'Part I - 0.3 mg BI 706321 Oral Solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG002', 'title': 'Part I - 0.6 mg BI 706321 Oral Solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG003', 'title': 'Part I - 1.2 mg BI 706321 Oral Solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG004', 'title': 'Part I - Placebo Capsules', 'description': 'Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.'}, {'id': 'BG005', 'title': 'Part I - 2 mg BI 706321 Capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG006', 'title': 'Part I - 4 mg BI 706321 Capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG007', 'title': 'Part I - 8 mg BI 706321 Capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG008', 'title': 'Part I - 15 mg BI 706321 Capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG009', 'title': 'Part I - 25 mg BI 706321 Capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.'}, {'id': 'BG010', 'title': 'Part II - R-T1-T2', 'description': 'Part II - R-T1-T2 - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Treatments in Part II were separated by a washout period of at least 12 days.'}, {'id': 'BG011', 'title': 'Part II - T1-T2-R', 'description': 'Part II - T1-T2-R - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.'}, {'id': 'BG012', 'title': 'Part II - T2-R-T1', 'description': 'Part II - T2-R-T1 - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '28.8', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '3.9', 'groupId': 'BG002'}, {'value': '32.8', 'spread': '4.4', 'groupId': 'BG003'}, {'value': '32.3', 'spread': '5.9', 'groupId': 'BG004'}, {'value': '29.2', 'spread': '4.9', 'groupId': 'BG005'}, {'value': '35.3', 'spread': '6.8', 'groupId': 'BG006'}, {'value': '30.2', 'spread': '6.2', 'groupId': 'BG007'}, {'value': '29.6', 'spread': '2.9', 'groupId': 'BG008'}, {'value': '32.2', 'spread': '7.8', 'groupId': 'BG009'}, {'value': '39.8', 'spread': '6.4', 'groupId': 'BG010'}, {'value': '42.0', 'spread': '11.5', 'groupId': 'BG011'}, {'value': '35.0', 'spread': '12.5', 'groupId': 'BG012'}, {'value': '32.6', 'spread': '6.9', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', '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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '73', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', '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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '73', 'groupId': 'BG013'}]}, {'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': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}]}], '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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'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': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Black or African American', '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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '73', 'groupId': 'BG013'}]}, {'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': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'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': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-07', 'size': 823632, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-27T04:18', 'hasProtocol': True}, {'date': '2021-01-14', 'size': 423277, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-27T04:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2019-05-31', 'resultsFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part I: Percentage of Subjects With Drug-related Adverse Events', 'timeFrame': "Between intake of trial medication and the individual subject's end of trial, up to 22 days.", 'description': 'Part I: Percentage of subjects with drug-related adverse events.'}, {'measure': 'Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.', 'description': 'Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).'}, {'measure': 'Part II: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.', 'description': 'Part II: Maximum measured concentration of BI 706321 in plasma (Cmax).'}], 'secondaryOutcomes': [{'measure': 'Part I: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.', 'description': 'Part I: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).'}, {'measure': 'Part I: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.', 'description': 'Part I: Maximum measured concentration of BI 706321 in plasma (Cmax).'}, {'measure': 'Part I: Time From Dosing to the Maximum Measured Concentration of BI 706321 in Plasma (Tmax)', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.', 'description': 'Part I: Time from dosing to the maximum measured concentration of BI 706321 in plasma (tmax).'}, {'measure': 'Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.', 'description': 'Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objectives are:\n\n* Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses.\n* Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR, oral body temperature), 12-lead ECG, and clinical laboratory tests\n* Age of 18 to 45 years (inclusive) in Part I and of 18 to 55 years (inclusive) in Part II\n* BMI of 18.5 to 29.9 kg/m2 (inclusive)\n* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including Blood Pressure (BP), (PR), oral body temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n* Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts\n* Chronic or relevant acute infections\n* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)\n* Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)\n* Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered\n* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)\n* Inability to refrain from smoking on specified trial days\n* Alcohol abuse (consumption of more than 24 g per day)\n* Drug abuse or positive drug screening\n* Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial\n* Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial\n* Inability to comply with the dietary regimen of the trial site\n* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening\n* A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)\n* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study\n* Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.\n* ALT (alanine transaminase), AST (aspartate transaminase), or creatinine exceed upper limit of normal range at screening, confirmed by a repeat test\n* During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection'}, 'identificationModule': {'nctId': 'NCT03971695', 'briefTitle': 'A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)', 'orgStudyIdInfo': {'id': '1425-0001'}, 'secondaryIdInfos': [{'id': '2019-000888-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part I - Placebo oral solution', 'description': 'Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 0.3 mg BI 706321 oral solution', 'description': 'Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 0.6 mg BI 706321 oral solution', 'description': 'Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 1.2 mg BI 706321 oral solution', 'description': 'Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part I - Placebo capsules', 'description': 'Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 2 mg BI 706321 capsules', 'description': 'Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 4 mg BI 706321 capsules', 'description': 'Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 8 mg BI 706321 capsules', 'description': 'Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 15 mg BI 706321 capsules', 'description': 'Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - 25 mg BI 706321 capsules', 'description': 'Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Test 1 (T1), fasted, tablets', 'description': 'Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Test 2 (T2), fed, tablets', 'description': 'Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast.', 'interventionNames': ['Drug: BI 706321']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Reference (R), fasted, capsules', 'description': 'Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 706321']}], 'interventions': [{'name': 'BI 706321', 'type': 'DRUG', 'description': 'Capsule or Oral Solution', 'armGroupLabels': ['Part I - 0.3 mg BI 706321 oral solution', 'Part I - 0.6 mg BI 706321 oral solution', 'Part I - 1.2 mg BI 706321 oral solution', 'Part I - 15 mg BI 706321 capsules', 'Part I - 2 mg BI 706321 capsules', 'Part I - 25 mg BI 706321 capsules', 'Part I - 4 mg BI 706321 capsules', 'Part I - 8 mg BI 706321 capsules', 'Part II - Reference (R), fasted, capsules', 'Part II - Test 1 (T1), fasted, tablets', 'Part II - Test 2 (T2), fed, tablets']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule or Oral solution', 'armGroupLabels': ['Part I - Placebo capsules', 'Part I - Placebo oral solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88397', 'city': 'Biberach', 'country': 'Germany', 'facility': 'Humanpharmakologisches Zentrum Biberach', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:\n\n1\\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}