Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT01505894
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
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 Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'Treated set was used for analysis of adverse events data.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chromatopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Maximum Concentration of BI 409306 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 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(Dose group 2).'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG006', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '245', 'spread': '130', 'groupId': 'OG000'}, {'value': '376', 'spread': '48.0', 'groupId': 'OG001'}, {'value': '565', 'spread': '84.6', 'groupId': 'OG002'}, {'value': '696', 'spread': '47.8', 'groupId': 'OG003'}, {'value': '1100', 'spread': '58.5', 'groupId': 'OG004'}, {'value': '1030', 'spread': '79.2', 'groupId': 'OG005'}, {'value': '1840', 'spread': '68.1', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On day 1, at -2:00 hours (pre dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.', 'description': 'Maximum measured concentration of the BI 409306 in plasma after first dose.', 'unitOfMeasure': 'Nanomoles/Litre (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG006', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.750', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.52'}, {'value': '0.500', 'groupId': 'OG001', 'lowerLimit': '0.167', 'upperLimit': '0.750'}, {'value': '0.500', 'groupId': 'OG002', 'lowerLimit': '0.333', 'upperLimit': '0.750'}, {'value': '0.750', 'groupId': 'OG003', 'lowerLimit': '0.333', 'upperLimit': '0.750'}, {'value': '0.333', 'groupId': 'OG004', 'lowerLimit': '0.167', 'upperLimit': '1.00'}, {'value': '0.500', 'groupId': 'OG005', 'lowerLimit': '0.333', 'upperLimit': '0.750'}, {'value': '0.500', 'groupId': 'OG006', 'lowerLimit': '0.333', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.', 'description': 'Time from dosing to maximum measured concentration of BI 409306 in plasma (Tmax) after the first dose.', 'unitOfMeasure': 'Hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG006', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '548', 'spread': '142', 'groupId': 'OG000'}, {'value': '594', 'spread': '48.6', 'groupId': 'OG001'}, {'value': '955', 'spread': '97.6', 'groupId': 'OG002'}, {'value': '1140', 'spread': '54.0', 'groupId': 'OG003'}, {'value': '1510', 'spread': '70.5', 'groupId': 'OG004'}, {'value': '1620', 'spread': '60.1', 'groupId': 'OG005'}, {'value': '2840', 'spread': '56.1', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.', 'description': 'Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after first dose.', 'unitOfMeasure': 'Nanomole*Hour/Litre (nmol*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG006', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '348', 'spread': '71.4', 'groupId': 'OG000'}, {'value': '444', 'spread': '44.2', 'groupId': 'OG001'}, {'value': '663', 'spread': '98.0', 'groupId': 'OG002'}, {'value': '596', 'spread': '42.8', 'groupId': 'OG003'}, {'value': '1250', 'spread': '76.6', 'groupId': 'OG004'}, {'value': '1260', 'spread': '55.4', 'groupId': 'OG005'}, {'value': '2150', 'spread': '87.0', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.', 'description': 'Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose.', 'unitOfMeasure': 'Nanomole/Litre (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG006', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.750', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '0.783'}, {'value': '0.500', 'groupId': 'OG001', 'lowerLimit': '0.333', 'upperLimit': '0.750'}, {'value': '0.625', 'groupId': 'OG002', 'lowerLimit': '0.333', 'upperLimit': '1.02'}, {'value': '0.750', 'groupId': 'OG003', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.417', 'groupId': 'OG004', 'lowerLimit': '0.167', 'upperLimit': '1.50'}, {'value': '0.500', 'groupId': 'OG005', 'lowerLimit': '0.333', 'upperLimit': '0.750'}, {'value': '0.333', 'groupId': 'OG006', 'lowerLimit': '0.167', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.', 'description': 'Time from last dosing until the maximum concentration of the analyte in plasma is reached at steady state after last dose on day 14.', 'unitOfMeasure': 'Hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG006', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '747', 'spread': '93.1', 'groupId': 'OG000'}, {'value': '621', 'spread': '55.8', 'groupId': 'OG001'}, {'value': '1070', 'spread': '125', 'groupId': 'OG002'}, {'value': '1100', 'spread': '52.4', 'groupId': 'OG003'}, {'value': '1710', 'spread': '83.6', 'groupId': 'OG004'}, {'value': '1960', 'spread': '64.3', 'groupId': 'OG005'}, {'value': '3990', 'spread': '119', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.', 'description': 'This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose on day 14.', 'unitOfMeasure': 'Nanomole*Hour/Litre (nmol*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics.'}, {'type': 'PRIMARY', 'title': 'Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.'}, {'id': 'OG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): Included all subjects who are treated with BI 409306.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.'}, {'id': 'OG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Vital signs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': '12-lead ECG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Clinical laboratory test', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Physical examiniation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Ophthalmological examination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Suicidality assessment', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'Number of participants with clinically relevant abnormal findings, as judged by investigator and reported as adverse event (AE), in vital signs (blood pressure, pulse rate, orthostatic test), 12-lead electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis) , physical examination, ophthalmological examination and suicidality assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): Included all subjects who are treated with BI 409306.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Per Category of Global Tolerability Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.'}, {'id': 'OG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'title': 'Good', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}, {'title': 'Satisfactory', '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': '1', 'groupId': 'OG008'}]}, {'title': 'Not satisfactory', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Not assessable', 'measurements': [{'value': '1', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'The investigator assessed tolerability based on adverse events and the laboratory evaluation and classified the overall tolerability according to the categories \'good\', \'satisfactory\', \'not satisfactory\', and \'bad\'. Investigator judgement based on clinical findings: "good" - No or mild adverse events (AEs) and no clinically significant (NCS) findings in any clinical assessments; "satisfactory" - mild or moderate AEs, NCS clinical findings; "not satisfactory" - moderate/severe AEs and/or clinically significant (CS) findings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): Included all subjects who are treated with BI 409306.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Findings in Color Discrimination Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.'}, {'id': 'OG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'Color vision was tested using the Ishihara test for color deficiency. The test consisted of a number of plates, called Ishihara plates, each of which contains a circle of dots of differing color and size. Within the pattern some dots form a number visible to those with normal color vision and invisible, or difficult to see, for those with a color vision deficiency. Participants with abnormal findings in color discrimination test are participants, who are not able to recognize the sign on the presented table.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): Included all subjects who are treated with BI 409306.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Findings in Visual Acuity Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.'}, {'id': 'OG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.'}, {'id': 'OG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'OG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'OG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], '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': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'Snellen chart was used to measure visual acuity. It measures the smallest line that a participant was able to read at a distance of 3 meter. Participants with abnormal findings in visual acuity test are participants, who are not able to recognize the letters on the line 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): Included all subjects who are treated with BI 409306.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.'}, {'id': 'FG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.'}, {'id': 'FG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'FG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'FG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'FG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'FG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'FG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'FG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This is randomised, placebo control, double blind, phase 1, pharmacokinetic study in healthy young and elderly subjects.', 'preAssignmentDetails': 'All participants were screened for eligibility to participate in the trial. Participants attended a specialist sites which ensured that they met all of the inclusion and none of exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria was violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '83', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo- Young Subjects', 'description': 'Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.'}, {'id': 'BG001', 'title': 'Placebo-Elderly Subjects Once Daily (QD)', 'description': 'Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.'}, {'id': 'BG002', 'title': 'BI 409306 25 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'BG003', 'title': 'BI 409306 25 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'BG004', 'title': 'BI 409306 50 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'BG005', 'title': 'BI 409306 50 Milligram- Young Subjects (BID)', 'description': 'Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).'}, {'id': 'BG006', 'title': 'BI 409306 50 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'BG007', 'title': 'BI 409306 100 Milligram- Young Subjects (QD)', 'description': 'Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'BG008', 'title': 'BI 409306 100 Milligram- Elderly Subjects (QD)', 'description': 'Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Young Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '48', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '41.8', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '42.2', 'spread': '6.6', 'groupId': 'BG002'}, {'value': '42.1', 'spread': '8.1', 'groupId': 'BG004'}, {'value': '41.9', 'spread': '7.9', 'groupId': 'BG005'}, {'value': '42.2', 'spread': '6.3', 'groupId': 'BG007'}, {'value': '42.0', 'spread': '7.6', 'groupId': 'BG009'}]}]}, {'title': 'Elderly Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '35', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '67.6', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '3.1', 'groupId': 'BG003'}, {'value': '70.5', 'spread': '4.0', 'groupId': 'BG006'}, {'value': '67.9', 'spread': '3.6', 'groupId': 'BG008'}, {'value': '68.7', 'spread': '3.5', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'description': 'Age in years off all subjects in the study', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Treated Set: Included all subjects who are treated with BI 409306.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '83', 'groupId': 'BG009'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '47', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender distribution of all subjects in the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'Treated Set: Included all subjects who are treated with BI 409306.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '83', 'groupId': 'BG009'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '82', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race of all included subjects in the study. Ethnicity data was not collected for this trial.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Treated Set: Included all subjects who are treated with BI 409306.'}], 'populationDescription': 'Treated Set: Included all subjects who are treated with BI 409306.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2012-01-05', 'resultsFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-10', 'studyFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product.'}, {'measure': 'Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'Number of participants with clinically relevant abnormal findings, as judged by investigator and reported as adverse event (AE), in vital signs (blood pressure, pulse rate, orthostatic test), 12-lead electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis) , physical examination, ophthalmological examination and suicidality assessment.'}, {'measure': 'Number of Participants Per Category of Global Tolerability Assessed by the Investigator', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'The investigator assessed tolerability based on adverse events and the laboratory evaluation and classified the overall tolerability according to the categories \'good\', \'satisfactory\', \'not satisfactory\', and \'bad\'. Investigator judgement based on clinical findings: "good" - No or mild adverse events (AEs) and no clinically significant (NCS) findings in any clinical assessments; "satisfactory" - mild or moderate AEs, NCS clinical findings; "not satisfactory" - moderate/severe AEs and/or clinically significant (CS) findings.'}, {'measure': 'Number of Participants With Abnormal Findings in Color Discrimination Test', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'Color vision was tested using the Ishihara test for color deficiency. The test consisted of a number of plates, called Ishihara plates, each of which contains a circle of dots of differing color and size. Within the pattern some dots form a number visible to those with normal color vision and invisible, or difficult to see, for those with a color vision deficiency. Participants with abnormal findings in color discrimination test are participants, who are not able to recognize the sign on the presented table.'}, {'measure': 'Number of Participants With Abnormal Findings in Visual Acuity Test', 'timeFrame': 'From first drug administration until the end-of-trial examination, up to 28 days.', 'description': 'Snellen chart was used to measure visual acuity. It measures the smallest line that a participant was able to read at a distance of 3 meter. Participants with abnormal findings in visual acuity test are participants, who are not able to recognize the letters on the line 3.'}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration of BI 409306 in Plasma (Cmax)', 'timeFrame': 'On day 1, at -2:00 hours (pre dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.', 'description': 'Maximum measured concentration of the BI 409306 in plasma after first dose.'}, {'measure': 'Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax)', 'timeFrame': 'On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.', 'description': 'Time from dosing to maximum measured concentration of BI 409306 in plasma (Tmax) after the first dose.'}, {'measure': 'Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.', 'description': 'Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after first dose.'}, {'measure': 'Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)', 'timeFrame': 'At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.', 'description': 'Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose.'}, {'measure': 'Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss)', 'timeFrame': 'At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.', 'description': 'Time from last dosing until the maximum concentration of the analyte in plasma is reached at steady state after last dose on day 14.'}, {'measure': 'Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss)', 'timeFrame': 'At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.', 'description': 'This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose on day 14.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.\n\nThe secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy males and females 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 for young healthy volunteers or Age \\>65 and Age \\<80 years for elderly healthy volunteers\n3. BMI \\>18.5 and BMI \\<29.9 kg/m2 (Body Mass Index)\n4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.\n5. For female subjects: Female subjects must be surgically sterilized or postmenopausal. Surgical sterilization or hysterectomy must have occurred at least 6 months prior to screening. Menopausal women must have no regular menstrual bleeding for at least 2 years prior to screening.\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)\n6. History or evidence of relevant orthostatic reaction (drop in systolic blood pressure (SBP) \\>20 mm Hg and increase in heart rate \\> 30 bpm after 2 minutes standing relative to supine data), fainting spells or blackouts.\n7. Chronic or relevant acute infections\n8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)\n9. Intake of any drugs within 14 days or drugs with a long half-life (\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial\n10. 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\n11. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial\n12. Smoker (\\> 5 cigarettes or \\> 1 cigars or \\> 1 pipes/day)\n13. Inability to refrain from smoking on trial days\n14. Alcohol abuse (more than 20 g/day)\n15. Drug abuse\n16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)\n17. Excessive physical activities (within one week prior to administration or during the trial)\n18. Any laboratory value outside the reference range that is of clinical relevance in the judgment of investigator\n19. Inability to comply with dietary regimen of trial site\n20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc F interval \\>430 ms in males and \\>450 ms in females);\n21. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);'}, 'identificationModule': {'nctId': 'NCT01505894', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. or Bid for 14 Days in Young Healthy and Elderly Healthy Male/Female Volunteers (Randomised, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)', 'orgStudyIdInfo': {'id': '1289.2'}, 'secondaryIdInfos': [{'id': '2011-002369-39', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Young Subjects', 'description': 'Placebo - Young Subjects', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Elderly Subjects', 'description': 'Placebo - Elderly Subjects', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 25 mg - Young Subjects QD', 'description': '25 milligram (mg) of BI 409306 were administered in young subjects once daily (QD).', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 25 mg - Elderly Subjects QD', 'description': '25 mg of BI 409306 were administered in elderly subjects once daily (QD).', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 50 mg - Young Subjects QD', 'description': '50 mg of BI 409306 were administered in young subjects once daily (QD).', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 50 mg - Young Subjects BID', 'description': '50 mg of BI 409306 were administered in young subjects twice daily (BID).', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 50 mg - Elderly Subjects QD', 'description': '50 mg of BI 409306 were administered in elderly subjects once daily', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 100 mg - Young Subjects QD', 'description': '100 mg of BI 409306 were administered in young subjects once daily (QD).', 'interventionNames': ['Drug: BI 409306']}, {'type': 'EXPERIMENTAL', 'label': 'BI 409306 100 mg - Elderly Subjects QD', 'description': '100 mg of BI 409306 were administered in elderly subjects once daily (QD).', 'interventionNames': ['Drug: BI 409306']}], 'interventions': [{'name': 'BI 409306', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['BI 409306 100 mg - Elderly Subjects QD', 'BI 409306 100 mg - Young Subjects QD', 'BI 409306 25 mg - Elderly Subjects QD', 'BI 409306 25 mg - Young Subjects QD', 'BI 409306 50 mg - Elderly Subjects QD', 'BI 409306 50 mg - Young Subjects BID', 'BI 409306 50 mg - Young Subjects QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Placebo - Elderly Subjects', 'Placebo - Young Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mannheim', 'country': 'Germany', 'facility': '1289.2.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], '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:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}