Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-30 @ 5:37 AM
Study NCT ID:
NCT01343706
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2011-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Tolerability and Pharmacokinetic of BI 409306
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630656', 'term': 'BI 409306'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 30 days after last drug administration; up to 31 days.', 'description': 'The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Matching to BI (Period 1)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Matching to BI (Period 2)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects administered placebo in period 2 (after a wash out period of 5 days).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking 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': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'BI 409306 50mg PiB [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chromatopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Parosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Drug-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching to BI (Period 1)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).'}, {'id': 'OG001', 'title': 'Placebo Matching to BI (Period 2)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects administered placebo in period 2 (after a wash out period of 5 days).'}, {'id': 'OG002', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG005', 'title': 'BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}, {'id': 'OG006', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG007', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG008', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.'}, {'id': 'OG009', 'title': 'BI 409306 50 mg PiB [EM]', 'description': 'Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG010', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG011', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG012', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG013', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG014', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '40.0', 'groupId': 'OG010'}, {'value': '66.7', 'groupId': 'OG011'}, {'value': '66.7', 'groupId': 'OG012'}, {'value': '33.3', 'groupId': 'OG013'}, {'value': '50.0', 'groupId': 'OG014'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration until 30 days after last drug administration; up to 31 days.', 'description': 'Percentage of subjects with investigator defined drug-related Adverse Events (AEs)', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Clinical Laboratory Tests, Oral Body Temperature and ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching to BI (Period 1)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).'}, {'id': 'OG001', 'title': 'Placebo Matching to BI (Period 2)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects administered placebo in period 2 (after a wash out period of 5 days).'}, {'id': 'OG002', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG005', 'title': 'BI 409306 5 mg Tablet EM', 'description': 'Subjects administered a single dose of 5 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours and after washout period of 5 days in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG006', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG007', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG008', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'Subjects administered one single dose of 50 mg BI 409306 immediate release tablets orally with 240 mL water after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG009', 'title': 'BI 409306 50 mg PiB [EM]', 'description': 'Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG010', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG011', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG012', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG013', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Subjects administered 2 single doses of 10 mg film-coated tablet of BI 409306 orally with 240 mL water after an overnight fast of at least 10 hours in poor metabolizer \\[PM\\] group.'}, {'id': 'OG014', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'Subjects administered 2 single doses of 100 mg film-coated tablet of BI 409306 orally with 240 mL water after an overnight fast of at least 10 hours in poor metabolizer \\[PM\\] group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 4', 'description': 'Percentage of subjects with Clinical Relevant abnormalities for Physical examination, Vital Signs blood pressure (BP), pulse rate (PR) respiratory rate (RR), orthostatic test), Clinical laboratory tests (haematology, clinical chemistry and urinalysis), Oral body temperature and ECG were reported.', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Per Category for Assessment of Tolerability by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching to BI 409306 [EM and PM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours.\n\nPoor metaboliser \\[PM\\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of placebo to BI 409306 tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}, {'id': 'OG001', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 409306 5 mg PiB Followed by BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}, {'id': 'OG004', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects were administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'BI 409306 50 mg Tablet Followed by BI 409306 50mg PiB [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.'}, {'id': 'OG007', 'title': 'Placebo to BI 409306 50 mg Tablet Followed by BI 409306 50 mg PiB [EM]', 'description': 'EM subject administered one single dose of placebo matching to the 50 mg BI 409306 film-coated tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution administered orally with 240 mL water in period 2, both after an overnight fast of at least 10 hours.'}, {'id': 'OG008', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG009', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG010', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG011', 'title': 'BI 409306 10 mg Tablet Followed by BI 409306 100mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}], 'classes': [{'title': 'Good', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Not assessable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 4', 'description': "The investigator assessed global clinical assessment and tolerability of BI 409306 were reported in possible categories were 'good', 'satisfactory', 'not satisfactory', and 'bad'.", 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching to BI (Period 1)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).'}, {'id': 'OG001', 'title': 'Placebo Matching to BI (Period 2)', 'description': 'Extensive metaboliser \\[EM\\] and poor metaboliser \\[PM\\] subjects administered placebo in period 2 (after a wash out period of 5 days).'}, {'id': 'OG002', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG005', 'title': 'BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}, {'id': 'OG006', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG007', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG008', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.'}, {'id': 'OG009', 'title': 'BI 409306 50 mg PiB [EM]', 'description': 'Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG010', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG011', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG012', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG013', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG014', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}], 'classes': [{'title': 'Alertness', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '-1.18', 'spread': '0.35', 'groupId': 'OG003'}, {'value': '-0.13', 'spread': '0.70', 'groupId': 'OG004'}, {'value': '0.09', 'spread': '0.56', 'groupId': 'OG005'}, {'value': '-0.33', 'spread': '0.73', 'groupId': 'OG006'}, {'value': '-0.07', 'spread': '0.97', 'groupId': 'OG007'}, {'value': '-0.92', 'spread': '1.25', 'groupId': 'OG008'}, {'value': '-0.56', 'spread': '0.54', 'groupId': 'OG009'}, {'value': '-0.26', 'spread': '0.95', 'groupId': 'OG010'}, {'value': '-0.80', 'spread': '0.55', 'groupId': 'OG011'}, {'value': '-0.21', 'spread': '0.39', 'groupId': 'OG012'}, {'value': '-1.02', 'spread': '1.24', 'groupId': 'OG013'}, {'value': '-1.88', 'spread': '1.58', 'groupId': 'OG014'}]}]}, {'title': 'Contentment', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-0.74', 'spread': '1.02', 'groupId': 'OG002'}, {'value': '-0.68', 'spread': '0.23', 'groupId': 'OG003'}, {'value': '-0.53', 'spread': '0.68', 'groupId': 'OG004'}, {'value': '-0.12', 'spread': '0.71', 'groupId': 'OG005'}, {'value': '0.04', 'spread': '0.46', 'groupId': 'OG006'}, {'value': '0.00', 'spread': '0.76', 'groupId': 'OG007'}, {'value': '-0.49', 'spread': '0.84', 'groupId': 'OG008'}, {'value': '-0.35', 'spread': '0.75', 'groupId': 'OG009'}, {'value': '-0.19', 'spread': '0.73', 'groupId': 'OG010'}, {'value': '-0.59', 'spread': '0.59', 'groupId': 'OG011'}, {'value': '-0.22', 'spread': '0.50', 'groupId': 'OG012'}, {'value': '-0.64', 'spread': '1.23', 'groupId': 'OG013'}, {'value': '-0.97', 'spread': '0.71', 'groupId': 'OG014'}]}]}, {'title': 'Calmness', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '-0.91', 'spread': '0.99', 'groupId': 'OG003'}, {'value': '-0.45', 'spread': '0.89', 'groupId': 'OG004'}, {'value': '-0.14', 'spread': '1.59', 'groupId': 'OG005'}, {'value': '0.25', 'spread': '1.04', 'groupId': 'OG006'}, {'value': '-0.39', 'spread': '0.55', 'groupId': 'OG007'}, {'value': '-0.75', 'spread': '1.35', 'groupId': 'OG008'}, {'value': '-0.47', 'spread': '1.71', 'groupId': 'OG009'}, {'value': '0.05', 'spread': '1.31', 'groupId': 'OG010'}, {'value': '-0.55', 'spread': '1.55', 'groupId': 'OG011'}, {'value': '-0.17', 'spread': '0.34', 'groupId': 'OG012'}, {'value': '-0.47', 'spread': '1.06', 'groupId': 'OG013'}, {'value': '-0.38', 'spread': '0.59', 'groupId': 'OG014'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 24 hours', 'description': 'The B\\&L VAS scores were calculated from 16 item with each has a score range from 0 to 10 \\[cm\\]. The score of each of the 3 categories of effects ("alertness", "calmness", and "contentment") is a weighted average of the scores from the 16 items. The VAS score for alertness/calmness/contentment ranges from 0 to 10 (more alertness/calmness/contentment). The B\\&L VAS data was analysed descriptively (change from baseline at 24 hour). The VAS assessment 2 h before drug administration was considered as baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG003', 'title': 'BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}, {'id': 'OG004', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG005', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG006', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.'}, {'id': 'OG007', 'title': 'BI 409306 50 mg PiB [EM]', 'description': 'Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG008', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG009', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG010', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG011', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG012', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.96', 'spread': '50.3', 'groupId': 'OG000'}, {'value': '20.90', 'spread': '41.30', 'groupId': 'OG001'}, {'value': '76.70', 'spread': '27.00', 'groupId': 'OG002'}, {'value': '75.60', 'spread': '32.29', 'groupId': 'OG003'}, {'value': '96.00', 'spread': '69.90', 'groupId': 'OG004'}, {'value': '351.00', 'spread': '49.30', 'groupId': 'OG005'}, {'value': '539.00', 'spread': '82.00', 'groupId': 'OG006'}, {'value': '648.00', 'spread': '42.90', 'groupId': 'OG007'}, {'value': '1460.00', 'spread': '68.50', 'groupId': 'OG008'}, {'value': '3920.00', 'spread': '44.40', 'groupId': 'OG009'}, {'value': '7980.00', 'spread': '17.10', 'groupId': 'OG010'}, {'value': '476.00', 'spread': '35.40', 'groupId': 'OG011'}, {'value': '6060.00', 'spread': '21.40', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.', 'description': 'AUC0-24, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 to the time of the last quantifiable data point is presented as geometric mean (gMean) and geometric coefficient of variation (gCV%). Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.', 'unitOfMeasure': 'nanomol*hour/Litre [nmol*h/L]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the BI 409306 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': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG003', 'title': 'BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}, {'id': 'OG004', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG005', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG006', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.'}, {'id': 'OG007', 'title': 'BI 409306 50 mg PiB [EM]', 'description': 'Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG008', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG009', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG010', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG011', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG012', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'spread': '50.40', 'groupId': 'OG000'}, {'value': '20.90', 'spread': '41.30', 'groupId': 'OG001'}, {'value': '76.70', 'spread': '27.00', 'groupId': 'OG002'}, {'value': '75.60', 'spread': '32.20', 'groupId': 'OG003'}, {'value': '95.90', 'spread': '69.80', 'groupId': 'OG004'}, {'value': '351.00', 'spread': '49.40', 'groupId': 'OG005'}, {'value': '539.00', 'spread': '82.00', 'groupId': 'OG006'}, {'value': '648.00', 'spread': '42.90', 'groupId': 'OG007'}, {'value': '1460.00', 'spread': '68.50', 'groupId': 'OG008'}, {'value': '3920.00', 'spread': '44.40', 'groupId': 'OG009'}, {'value': '7980.00', 'spread': '17.10', 'groupId': 'OG010'}, {'value': '476.00', 'spread': '35.50', 'groupId': 'OG011'}, {'value': '6060.00', 'spread': '21.40', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.', 'description': 'AUC0-∞, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 extrapolated to infinity. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.', 'unitOfMeasure': 'nanomol*hour/Litre [nmol*h/L]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG003', 'title': 'BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}, {'id': 'OG004', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG005', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG006', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.'}, {'id': 'OG007', 'title': 'BI 409306 50 mg PiB [EM]', 'description': 'Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG008', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG009', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG010', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG011', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG012', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.54', 'spread': '34.50', 'groupId': 'OG000'}, {'value': '18.80', 'spread': '50.80', 'groupId': 'OG001'}, {'value': '56.40', 'spread': '36.40', 'groupId': 'OG002'}, {'value': '55.90', 'spread': '40.90', 'groupId': 'OG003'}, {'value': '99.80', 'spread': '79.10', 'groupId': 'OG004'}, {'value': '300.00', 'spread': '85.00', 'groupId': 'OG005'}, {'value': '479.00', 'spread': '67.00', 'groupId': 'OG006'}, {'value': '613.00', 'spread': '40.70', 'groupId': 'OG007'}, {'value': '1370.00', 'spread': '87.30', 'groupId': 'OG008'}, {'value': '2950.00', 'spread': '89.50', 'groupId': 'OG009'}, {'value': '5540.00', 'spread': '29.50', 'groupId': 'OG010'}, {'value': '223.00', 'spread': '38.10', 'groupId': 'OG011'}, {'value': '3120.00', 'spread': '31.40', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.', 'description': 'Cmax, Maximum measured concentration of the BI 409306 in plasma. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.', 'unitOfMeasure': 'nanomol/Litre (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax.'}, {'type': 'SECONDARY', 'title': 'Amount of BI 409306 Eliminated in Urine From the Time Point t1 to Time Point t2 (Ae0-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 409306 5 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG003', 'title': 'BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}, {'id': 'OG004', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG005', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG006', 'title': 'BI 409306 50 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.'}, {'id': 'OG007', 'title': 'BI 409306 50 mg PiB [EM]', 'description': 'Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG008', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG009', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG010', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \\[EM\\] group.'}, {'id': 'OG011', 'title': 'BI 409306 10 mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.'}, {'id': 'OG012', 'title': 'BI 409306 100 mg Tablet [PM]', 'description': 'PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '31.00', 'spread': '46.50', 'groupId': 'OG001'}, {'value': '93.60', 'spread': '26.00', 'groupId': 'OG002'}, {'value': '98.10', 'spread': '24.20', 'groupId': 'OG003'}, {'value': '148.00', 'spread': '60.20', 'groupId': 'OG004'}, {'value': '840.00', 'spread': '56.90', 'groupId': 'OG006'}, {'value': '953.00', 'spread': '48.10', 'groupId': 'OG007'}, {'value': '1920.00', 'spread': '53.00', 'groupId': 'OG008'}, {'value': '4340.00', 'spread': '48.80', 'groupId': 'OG009'}, {'value': '8830.00', 'spread': '24.00', 'groupId': 'OG010'}, {'value': '418.00', 'spread': '14.30', 'groupId': 'OG011'}, {'value': '5700.00', 'spread': '23.30', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Urine samples were obtained pre-dose and sampling intervals 0:00 to 4:00, 4:00 to 8:00, 8:00 to 12:00 and 12:00 to 24:00 hours after oral administration.', 'description': 'Ae0-4, Amount of BI 409306 eliminated in urine from the time point t1(0) to time point t2(4). Urine samples were obtained 24:00 to 48:00 and 48:00 to 72:00 hours after oral administration were obtained only from dose group 10 mg onwards.', 'unitOfMeasure': 'nanomol [nmol]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax. Only participants with non-missing outcomes were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Matching to BI 409306 [EM and PM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours.\n\nPoor metaboliser \\[PM\\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of placebo to BI 409306 tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}, {'id': 'FG001', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'FG002', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'FG003', 'title': 'BI 409306 5 mg PiB Followed by BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}, {'id': 'FG004', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG005', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG006', 'title': 'BI 409306 50 mg Tablet Followed by BI 409306 50mg PiB [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.'}, {'id': 'FG007', 'title': 'Placebo to BI 409306 50 mg Tablet Followed by BI 409306 50 mg PiB [EM]', 'description': 'EM subject administered one single dose of placebo matching to the 50 mg BI 409306 film-coated tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution administered orally with 240 mL water in period 2, both after an overnight fast of at least 10 hours.'}, {'id': 'FG008', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG009', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG010', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG011', 'title': 'BI 409306 10 mg Tablet Followed by BI 409306 100mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Entered subjects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '6'}]}, {'type': 'Not Treated', 'comment': 'Subject withdrew before the first drug administration', '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': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed planned observation time', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '6'}]}, {'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': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'In this Phase 1, single centre, placebo-controlled trial (within dose groups), total of 80 healthy subjects were entered and 79 (71 CYP2C19 Extensive metaboliser /8 Poor CYP2C19 metaboliser) subjects were treated in 10 sequential dose groups.', 'preAssignmentDetails': 'All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were not met.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '79', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Matching to BI 409306 [EM and PM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours.\n\nPoor metaboliser \\[PM\\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of placebo to BI 409306 tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}, {'id': 'BG001', 'title': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'BG002', 'title': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.'}, {'id': 'BG003', 'title': 'BI 409306 5 mg PiB Followed by BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}, {'id': 'BG004', 'title': 'BI 409306 10 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG005', 'title': 'BI 409306 25 mg Tablet [EM]', 'description': 'EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG006', 'title': 'BI 409306 50 mg Tablet Followed by BI 409306 50mg PiB [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.'}, {'id': 'BG007', 'title': 'Placebo to BI 409306 50 mg Tablet Followed by BI 409306 50 mg PiB [EM]', 'description': 'EM subject administered one single dose of placebo matching to the 50 mg BI 409306 film-coated tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution administered orally with 240 mL water in period 2, both after an overnight fast of at least 10 hours.'}, {'id': 'BG008', 'title': 'BI 409306 100 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG009', 'title': 'BI 409306 200 mg Tablet [EM]', 'description': 'EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG010', 'title': 'BI 409306 350 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG011', 'title': 'BI 409306 10 mg Tablet Followed by BI 409306 100mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '36.5', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '37.5', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '35.7', 'spread': '8.2', 'groupId': 'BG003'}, {'value': '30.5', 'spread': '5.9', 'groupId': 'BG004'}, {'value': '32.2', 'spread': '6.5', 'groupId': 'BG005'}, {'value': '40.3', 'spread': '6.1', 'groupId': 'BG006'}, {'value': '37.5', 'spread': '3.5', 'groupId': 'BG007'}, {'value': '31.4', 'spread': '7.3', 'groupId': 'BG008'}, {'value': '38.5', 'spread': '6.7', 'groupId': 'BG009'}, {'value': '39.2', 'spread': '8.8', 'groupId': 'BG010'}, {'value': '39.5', 'spread': '7.5', 'groupId': 'BG011'}, {'value': '36.7', 'spread': '7.1', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'description': 'Age at the time of signing informed consent form is presented.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'TS'}, {'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'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '79', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of subjects is categorized as Male or Female.', 'unitOfMeasure': 'Participants', 'populationDescription': 'TS'}, {'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'}]}, {'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'}]}, {'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'}]}, {'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'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '79', 'groupId': 'BG012'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of subjects is categorized for race data. Ethnicity data were not collected.', 'unitOfMeasure': 'Participants', 'populationDescription': 'TS'}], 'populationDescription': 'Treated set (TS): The treated set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2011-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2011-04-06', 'resultsFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-10', 'studyFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Drug-related Adverse Events', 'timeFrame': 'From first drug administration until 30 days after last drug administration; up to 31 days.', 'description': 'Percentage of subjects with investigator defined drug-related Adverse Events (AEs)'}, {'measure': 'Percentage of Subjects With Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Clinical Laboratory Tests, Oral Body Temperature and ECG', 'timeFrame': 'Day 4', 'description': 'Percentage of subjects with Clinical Relevant abnormalities for Physical examination, Vital Signs blood pressure (BP), pulse rate (PR) respiratory rate (RR), orthostatic test), Clinical laboratory tests (haematology, clinical chemistry and urinalysis), Oral body temperature and ECG were reported.'}, {'measure': 'Percentage of Subjects Per Category for Assessment of Tolerability by Investigator', 'timeFrame': 'Day 4', 'description': "The investigator assessed global clinical assessment and tolerability of BI 409306 were reported in possible categories were 'good', 'satisfactory', 'not satisfactory', and 'bad'."}, {'measure': 'Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)', 'timeFrame': 'At 24 hours', 'description': 'The B\\&L VAS scores were calculated from 16 item with each has a score range from 0 to 10 \\[cm\\]. The score of each of the 3 categories of effects ("alertness", "calmness", and "contentment") is a weighted average of the scores from the 16 items. The VAS score for alertness/calmness/contentment ranges from 0 to 10 (more alertness/calmness/contentment). The B\\&L VAS data was analysed descriptively (change from baseline at 24 hour). The VAS assessment 2 h before drug administration was considered as baseline.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of the BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-24)', 'timeFrame': 'Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.', 'description': 'AUC0-24, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 to the time of the last quantifiable data point is presented as geometric mean (gMean) and geometric coefficient of variation (gCV%). Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.'}, {'measure': 'Area Under the Concentration-time Curve of the BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.', 'description': 'AUC0-∞, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 extrapolated to infinity. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.'}, {'measure': 'Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)', 'timeFrame': 'Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.', 'description': 'Cmax, Maximum measured concentration of the BI 409306 in plasma. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.'}, {'measure': 'Amount of BI 409306 Eliminated in Urine From the Time Point t1 to Time Point t2 (Ae0-4)', 'timeFrame': 'Urine samples were obtained pre-dose and sampling intervals 0:00 to 4:00, 4:00 to 8:00, 8:00 to 12:00 and 12:00 to 24:00 hours after oral administration.', 'description': 'Ae0-4, Amount of BI 409306 eliminated in urine from the time point t1(0) to time point t2(4). Urine samples were obtained 24:00 to 48:00 and 48:00 to 72:00 hours after oral administration were obtained only from dose group 10 mg onwards.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses.\n\nThe secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests\n2. Age \\> 21 and Age \\< 50 years\n3. Body Mass Index (BMI) \\> 18.5 and BMI \\< 29.9 kg/m2\n\nExclusion criteria:\n\n1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance\n2. Any evidence of a clinically relevant concomitant disease\n3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n4. Surgery of the gastrointestinal tract (except appendectomy)\n5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month\n6. History of relevant orthostatic hypotension, fainting spells or blackouts.\n7. Chronic or relevant acute infections\n8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)\n9. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial\n10. Any laboratory value outside the reference range that is of clinical relevance\n11. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\>450 ms);\n12. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)'}, 'identificationModule': {'nctId': 'NCT01343706', 'briefTitle': 'Safety Tolerability and Pharmacokinetic of BI 409306', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses 0.5 mg to 500 mg of BI 409306 Administered Orally in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '1289.1'}, 'secondaryIdInfos': [{'id': '2010-023604-27', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 409306 0.5 mg PiB [EM]', 'description': 'Extensive metaboliser \\[EM\\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 2 mg PiB [EM]', 'description': 'EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM]', 'description': 'EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 10 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 25 mg Tablet [EM]', 'description': 'EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]', 'description': 'EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 100 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 200 mg Tablet [EM]', 'description': 'EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 350 mg Tablet [EM]', 'description': 'EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 10 mg Tablet followed by BI 409306 100mg Tablet [PM]', 'description': 'Poor metaboliser \\[PM\\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.', 'interventionNames': ['Drug: BI 409306']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matching to BI 409306 PiB', 'description': 'Subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matching to BI 409306 film-coated tablet', 'description': 'Subjects administered one single dose of placebo matching to the BI 409306 film-coated tablet (5 milligrams (mg), 50 mg, and 150 mg) orally with 240 mL water after an overnight fast of at least 10 hours.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for oral administration', 'armGroupLabels': ['Placebo matching to BI 409306 PiB']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Immediate release solid oral dosage (film-coated tablet)', 'armGroupLabels': ['Placebo matching to BI 409306 film-coated tablet']}, {'name': 'BI 409306', 'type': 'DRUG', 'description': 'Immediate release solid oral dosage (film-coated tablet)', 'armGroupLabels': ['BI 409306 10 mg Tablet [EM]', 'BI 409306 10 mg Tablet followed by BI 409306 100mg Tablet [PM]', 'BI 409306 100 mg Tablet [EM]', 'BI 409306 200 mg Tablet [EM]', 'BI 409306 25 mg Tablet [EM]', 'BI 409306 350 mg Tablet [EM]', 'BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM]', 'BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]']}, {'name': 'BI 409306', 'type': 'DRUG', 'description': 'solution for oral administration', 'armGroupLabels': ['BI 409306 0.5 mg PiB [EM]', 'BI 409306 2 mg PiB [EM]', 'BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM]', 'BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ingelheim', 'country': 'Germany', 'facility': '1289.1.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, '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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}