Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-04-19 @ 1:20 AM
Study NCT ID:
NCT01763333
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2013-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.', 'eventGroups': [{'id': 'EG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition.', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Placebo (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.', 'otherNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'BI 1026706 - Solution 100 mg Fasted (R2)', 'description': 'Subjects were treated with 100 mg drinking solution (R2) under fasting condition.', 'otherNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'BI 1026706 - 100 mg Solution Fed (T2)', 'description': 'Subjects were treated with 100 mg drinking solution (T2) under fed condition.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'BI 1026706 - Tablet 100 mg Fasted (R1)', 'description': 'Subjects were treated with 100mg film coated tablet (R1) under fasted condition.', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'BI 1026706 - Tablet 100 mg Fed (T1)', 'description': 'Subjects were treated with 100mg film coated tablet (T1) under fed condition.', 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Application site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Tendon pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Drug Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'OG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'OG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'OG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'OG009', 'title': 'Placebo (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.'}, {'id': 'OG010', 'title': 'BI 1026706 - Solution 100 mg Fasted (R2)', 'description': 'Subjects were treated with 100 mg drinking solution (R2) under fasting condition.'}, {'id': 'OG011', 'title': 'BI 1026706 - 100 mg Solution Fed (T2)', 'description': 'Subjects were treated with 100 mg drinking solution (T2) under fed condition.'}, {'id': 'OG012', 'title': 'BI 1026706 - Tablet 100 mg Fasted (R1)', 'description': 'Subjects were treated with 100mg film coated tablet (R1) under fasted condition.'}, {'id': 'OG013', 'title': 'BI 1026706 - Tablet 100 mg Fed (T1)', 'description': 'Subjects were treated with 100mg film coated tablet (T1) under fed condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '20.0', 'groupId': 'OG006'}, {'value': '16.7', 'groupId': 'OG007'}, {'value': '60.0', 'groupId': 'OG008'}, {'value': '22.2', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '8.3', 'groupId': 'OG011'}, {'value': '16.7', 'groupId': 'OG012'}, {'value': '20.0', 'groupId': 'OG013'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.', 'description': 'Percentage of subjects with drug related adverse events.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The treated set (TS) included all subjects who were documented to have taken at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'OG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'OG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'OG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'OG009', 'title': 'BI 1026706 - Solution 100 mg Fasted (R2)', 'description': 'Subjects were treated with 100 mg drinking solution (R2) under fasting condition.'}, {'id': 'OG010', 'title': 'BI 1026706 - 100 mg Solution Fed (T2)', 'description': 'Subjects were treated with 100 mg drinking solution (T2) under fed condition.'}, {'id': 'OG011', 'title': 'BI 1026706 - Tablet 100 mg Fasted (R1)', 'description': 'Subjects were treated with 100mg film coated tablet (R1) under fasted condition.'}, {'id': 'OG012', 'title': 'BI 1026706 - Tablet 100 mg Fed (T1)', 'description': 'Subjects were treated with 100mg film coated tablet (T1) under fed condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '268', 'spread': '42.9', 'groupId': 'OG001'}, {'value': '623', 'spread': '40.9', 'groupId': 'OG002'}, {'value': '728', 'spread': '26.8', 'groupId': 'OG003'}, {'value': '1430', 'spread': '80.0', 'groupId': 'OG004'}, {'value': '112', 'spread': '32.9', 'groupId': 'OG005'}, {'value': '1150', 'spread': '47.1', 'groupId': 'OG006'}, {'value': '2210', 'spread': '28.0', 'groupId': 'OG007'}, {'value': '3090', 'spread': '24.8', 'groupId': 'OG008'}, {'value': '1340', 'spread': '32.0', 'groupId': 'OG009'}, {'value': '706', 'spread': '33.5', 'groupId': 'OG010'}, {'value': '560', 'spread': '34.8', 'groupId': 'OG011'}, {'value': '651', 'spread': '34.4', 'groupId': 'OG012'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8728', 'ciLowerLimit': '0.6942', 'ciUpperLimit': '1.0513', 'estimateComment': 'Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.', 'groupDescription': 'This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG006', 'OG007', 'OG008'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9341', 'ciLowerLimit': '0.8277', 'ciUpperLimit': '1.0405', 'estimateComment': 'Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.', 'groupDescription': 'This was non confirmatory testing (Single dose). Dose proportionality of solution for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG011', 'OG012'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '112.74', 'ciLowerLimit': '95.579', 'ciUpperLimit': '132.993', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '52.66', 'ciLowerLimit': '40.488', 'ciUpperLimit': '68.499', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}, {'groupIds': ['OG009', 'OG011'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '239.63', 'ciLowerLimit': '197.445', 'ciUpperLimit': '290.830', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}, {'groupIds': ['OG010', 'OG012'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.47', 'ciLowerLimit': '85.427', 'ciUpperLimit': '130.208', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Maximum measured concentration of the analyte in plasma (Cmax).\n\nThe treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part.\n\nThe per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) included all subjects of the TS-BA who provided observations under the reference treatment (R1) or test treatment (T1) for at least one of the endpoints Cmax, AUC0-tz, or AUC0-inf,without experiencing emesis at or before two times median tmax and without important protocol violations (PVs) relevant to the statistical evaluation of pharmacokinetic (PK). The same definition applies for the analysis set PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1.', 'unitOfMeasure': 'nanomoles Per Litre (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1'}, {'type': 'SECONDARY', 'title': 'Tmax (Time From Dosing to Maximum Measured Concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'OG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'OG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'OG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'OG009', 'title': 'BI 1026706 - Solution 100 mg Fasted (R2)', 'description': 'Subjects were treated with 100 mg drinking solution (R2) under fasting condition.'}, {'id': 'OG010', 'title': 'BI 1026706 - 100 mg Solution Fed (T2)', 'description': 'Subjects were treated with 100 mg drinking solution (T2) under fed condition.'}, {'id': 'OG011', 'title': 'BI 1026706 - Tablet 100 mg Fasted (R1)', 'description': 'Subjects were treated with 100mg film coated tablet (R1) under fasted condition.'}, {'id': 'OG012', 'title': 'BI 1026706 - Tablet 100 mg Fed (T1)', 'description': 'Subjects were treated with 100mg film coated tablet (T1) under fed condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '4.07'}, {'value': '1.51', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.75', 'groupId': 'OG002', 'lowerLimit': '0.73', 'upperLimit': '4.02'}, {'value': '1.25', 'groupId': 'OG003', 'lowerLimit': '0.76', 'upperLimit': '4.02'}, {'value': '2.23', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '0.63', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '0.50', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '0.76'}, {'value': '0.75', 'groupId': 'OG007', 'lowerLimit': '0.42', 'upperLimit': '0.75'}, {'value': '0.75', 'groupId': 'OG008', 'lowerLimit': '0.42', 'upperLimit': '1.00'}, {'value': '0.52', 'groupId': 'OG009', 'lowerLimit': '0.50', 'upperLimit': '0.75'}, {'value': '0.75', 'groupId': 'OG010', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '1.74', 'groupId': 'OG011', 'lowerLimit': '0.75', 'upperLimit': '3.02'}, {'value': '1.26', 'groupId': 'OG012', 'lowerLimit': '0.50', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Time from dosing to maximum measured concentration (tmax).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part.'}, {'type': 'SECONDARY', 'title': 'AUC0-inf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'OG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'OG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'OG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'OG009', 'title': 'BI 1026706 - Solution 100 mg Fasted (R2)', 'description': 'Subjects were treated with 100 mg drinking solution (R2) under fasting condition.'}, {'id': 'OG010', 'title': 'BI 1026706 - 100 mg Solution Fed (T2)', 'description': 'Subjects were treated with 100 mg drinking solution (T2) under fed condition.'}, {'id': 'OG011', 'title': 'BI 1026706 - Tablet 100 mg Fasted (R1)', 'description': 'Subjects were treated with 100mg film coated tablet (R1) under fasted condition.'}, {'id': 'OG012', 'title': 'BI 1026706 - Tablet 100 mg Fed (T1)', 'description': 'Subjects were treated with 100mg film coated tablet (T1) under fed condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '768', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '1690', 'spread': '51.8', 'groupId': 'OG001'}, {'value': '3990', 'spread': '30.9', 'groupId': 'OG002'}, {'value': '4040', 'spread': '29.4', 'groupId': 'OG003'}, {'value': '8900', 'spread': '85.1', 'groupId': 'OG004'}, {'value': '428', 'spread': '41.9', 'groupId': 'OG005'}, {'value': '3220', 'spread': '43.5', 'groupId': 'OG006'}, {'value': '7790', 'spread': '26.9', 'groupId': 'OG007'}, {'value': '11300', 'spread': '28.3', 'groupId': 'OG008'}, {'value': '4590', 'spread': '33.1', 'groupId': 'OG009'}, {'value': '3380', 'spread': '28.6', 'groupId': 'OG010'}, {'value': '3270', 'spread': '28.3', 'groupId': 'OG011'}, {'value': '2930', 'spread': '40.8', 'groupId': 'OG012'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8341', 'ciLowerLimit': '0.6485', 'ciUpperLimit': '1.0198', 'estimateComment': 'Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.', 'groupDescription': 'This was non confirmatory testing (Single dose).Dose proportionality of tablets for AUC0-inf was analysed.The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG006', 'OG007', 'OG008'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9149', 'ciLowerLimit': '0.8059', 'ciUpperLimit': '1.0239', 'estimateComment': 'Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.', 'groupDescription': 'This was non confirmatory testing (Single dose).Dose proportionality of solution for AUC0-inf was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG011', 'OG012'], 'paramType': 'gMean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.61', 'ciLowerLimit': '76.529', 'ciUpperLimit': '98.029', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for AUC0-inf. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '74.44', 'ciLowerLimit': '66.322', 'ciUpperLimit': '83.562', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}, {'groupIds': ['OG009', 'OG011'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '137.25', 'ciLowerLimit': '119.708', 'ciUpperLimit': '157.353', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}, {'groupIds': ['OG010', 'OG012'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '116.48', 'ciLowerLimit': '111.462', 'ciUpperLimit': '121.724', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1'}, {'type': 'SECONDARY', 'title': 'AUC0- tz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'OG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'OG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'OG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'OG009', 'title': 'BI 1026706 - Solution 100 mg Fasted (R2)', 'description': 'Subjects were treated with 100 mg drinking solution (R2) under fasting condition.'}, {'id': 'OG010', 'title': 'BI 1026706 - 100 mg Solution Fed (T2)', 'description': 'Subjects were treated with 100 mg drinking solution (T2) under fed condition.'}, {'id': 'OG011', 'title': 'BI 1026706 - Tablet 100 mg Fasted (R1)', 'description': 'Subjects were treated with 100mg film coated tablet (R1) under fasted condition.'}, {'id': 'OG012', 'title': 'BI 1026706 - Tablet 100 mg Fed (T1)', 'description': 'Subjects were treated with 100mg film coated tablet (T1) under fed condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '741', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '1670', 'spread': '51.8', 'groupId': 'OG001'}, {'value': '3950', 'spread': '30.5', 'groupId': 'OG002'}, {'value': '3990', 'spread': '28.6', 'groupId': 'OG003'}, {'value': '8830', 'spread': '85.3', 'groupId': 'OG004'}, {'value': '403', 'spread': '44.0', 'groupId': 'OG005'}, {'value': '3170', 'spread': '27.0', 'groupId': 'OG006'}, {'value': '7710', 'spread': '27.0', 'groupId': 'OG007'}, {'value': '11300', 'spread': '28.3', 'groupId': 'OG008'}, {'value': '4550', 'spread': '33.3', 'groupId': 'OG009'}, {'value': '3360', 'spread': '28.9', 'groupId': 'OG010'}, {'value': '3240', 'spread': '28.3', 'groupId': 'OG011'}, {'value': '2900', 'spread': '40.8', 'groupId': 'OG012'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG004'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8428', 'ciLowerLimit': '0.6580', 'ciUpperLimit': '1.0275', 'estimateComment': 'Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.', 'groupDescription': 'This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC 0- tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG006', 'OG007', 'OG008'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9307', 'ciLowerLimit': '0.8187', 'ciUpperLimit': '1.0426', 'estimateComment': 'Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.', 'groupDescription': 'This was non confirmatory testing (Single dose). Dose proportionality of solution for AUC0-tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG011', 'OG012'], 'paramType': 'gMean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.16', 'ciLowerLimit': '75.735', 'ciUpperLimit': '98.027', 'estimateComment': 'Adjusted geometric mean (gMean) ratio.', 'groupDescription': 'Relative bioavailability comparison Tab. fed (T1) : Tab. fasted (R1) for AUC 0-tz. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '74.42', 'ciLowerLimit': '65.979', 'ciUpperLimit': '83.941', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)'}, {'groupIds': ['OG009', 'OG011'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '137.20', 'ciLowerLimit': '119.611', 'ciUpperLimit': '157.374', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of R2 vs R1(PPS-BA-R2-R1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}, {'groupIds': ['OG010', 'OG012'], 'paramType': 'gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '116.83', 'ciLowerLimit': '111.814', 'ciUpperLimit': '122.079', 'estimateComment': 'Adjusted gMean ratio.', 'groupDescription': 'Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0- tz).', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1'}, {'type': 'SECONDARY', 'title': 't1/2 (Terminal Half-life of the Analyte in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'OG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'OG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'OG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'OG009', 'title': 'BI 1026706 - Solution 100 mg Fasted (R2)', 'description': 'Subjects were treated with 100 mg drinking solution (R2) under fasting condition.'}, {'id': 'OG010', 'title': 'BI 1026706 - 100 mg Solution Fed (T2)', 'description': 'Subjects were treated with 100 mg drinking solution (T2) under fed condition.'}, {'id': 'OG011', 'title': 'BI 1026706 - Tablet 100 mg Fasted (R1)', 'description': 'Subjects were treated with 100mg film coated tablet (R1) under fasted condition.'}, {'id': 'OG012', 'title': 'BI 1026706 - Tablet 100 mg Fed (T1)', 'description': 'Subjects were treated with 100mg film coated tablet (T1) under fed condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.80', 'spread': '75.7', 'groupId': 'OG000'}, {'value': '8.58', 'spread': '54.3', 'groupId': 'OG001'}, {'value': '12.10', 'spread': '26.6', 'groupId': 'OG002'}, {'value': '11.60', 'spread': '43.2', 'groupId': 'OG003'}, {'value': '12.00', 'spread': '22.7', 'groupId': 'OG004'}, {'value': '13.90', 'spread': '82.1', 'groupId': 'OG005'}, {'value': '12.80', 'spread': '54.7', 'groupId': 'OG006'}, {'value': '11.50', 'spread': '50.3', 'groupId': 'OG007'}, {'value': '9.29', 'spread': '27.3', 'groupId': 'OG008'}, {'value': '10.80', 'spread': '36.0', 'groupId': 'OG009'}, {'value': '11.10', 'spread': '53.9', 'groupId': 'OG010'}, {'value': '10.50', 'spread': '46.9', 'groupId': 'OG011'}, {'value': '12.60', 'spread': '28.4', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Terminal half-life of the analyte in plasma (t1/2).', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS-SRD and TS-BA'}, {'type': 'SECONDARY', 'title': 'f t1-t2 (SRD-Part)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'OG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'OG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'OG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'OG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '51.2', 'groupId': 'OG001'}, {'value': '3.43', 'spread': '33.4', 'groupId': 'OG002'}, {'value': '1.95', 'spread': '27.2', 'groupId': 'OG003'}, {'value': '1.87', 'spread': '45.3', 'groupId': 'OG004'}, {'value': '3.97', 'spread': '40.8', 'groupId': 'OG005'}, {'value': '3.47', 'spread': '23.9', 'groupId': 'OG006'}, {'value': '3.82', 'spread': '32.8', 'groupId': 'OG007'}, {'value': '2.09', 'spread': '7.44', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours', 'description': 'Fraction of analyte eliminated in urine from the time point t1 (0h) to time point t2 (72h) (f t1-t2).', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS-SRD'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'FG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'FG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'FG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'FG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'FG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'FG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'FG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'FG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'FG009', 'title': 'Placebo (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.'}, {'id': 'FG010', 'title': 'R1/T1/R2/T2 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100mg film coated tablet (R1) under fasted condition, followed by 100mg film coated tablet (T1) under fed condition, 100 mg drinking solution (R2) under fasting and in the last treatment period with 100 mg drinking solution (T2) under fed condition. There was washout period of 7days between the respective treatments.'}, {'id': 'FG011', 'title': 'T1/T2/R1/R2 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning. First they were treated with 100mg film coated tablet (T1) under fed condition, followed by 100 mg drinking solution (T2) under fed condition, 100mg film coated tablet (R1) under fasted condition and in the last treatment period with 100 mg drinking solution (R2) under fasting condition. There was a washout period of 7days between the respective treatments.'}, {'id': 'FG012', 'title': 'R2/R1/T2/T1 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (R2) under fasting condition, followed by 100mg film coated tablet (R1) under fasted condition,100 mg drinking solution (T2) under fed condition and in the last treatment period with 100mg film coated tablet (T1) under fed condition. There was washout period of 7days between the respective treatments.'}, {'id': 'FG013', 'title': 'T2/R2/T1/R1 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (T2) under fed condition, followed by 100 mg drinking solution (R2) under fasting, 100mg film coated tablet (T1) under fed condition and in the last treatment period with 100mg film coated tablet (R1) under fasted condition. There was washout period of 7days between the respective treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '18'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '18'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Subjects were recruited from the volunteers' pool of the Human Pharmacology Centre of Boehringer Ingelheim (BI) Pharma GmbH \\& Co. KG, Ingelheim, Germany.Only male subjects were included because no data on reproductive toxicology was available.", 'preAssignmentDetails': '68 subjects were randomised for single rising dose (SRD) part \\&12 subjects for bioavailability(BA) part of study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '80', 'groupId': 'BG014'}]}], 'groups': [{'id': 'BG000', 'title': 'BI 1026706 - Tablet 25 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'BG001', 'title': 'BI 1026706 - Tablet 50 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'BG002', 'title': 'BI 1026706 - Tablet 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'BG003', 'title': 'BI 1026706 - Tablet 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'BG004', 'title': 'BI 1026706 - Tablet 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition.'}, {'id': 'BG005', 'title': 'BI 1026706 - Solution 10 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition.'}, {'id': 'BG006', 'title': 'BI 1026706 - Solution 100 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition'}, {'id': 'BG007', 'title': 'BI 1026706 - Solution 200 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition.'}, {'id': 'BG008', 'title': 'BI 1026706 - Solution 400 mg (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition.'}, {'id': 'BG009', 'title': 'Placebo (SRD - Part)', 'description': 'Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition.'}, {'id': 'BG010', 'title': 'R1/T1/R2/T2 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100mg film coated tablet (R1) under fasted condition, followed by 100mg film coated tablet (T1) under fed condition, 100 mg drinking solution (R2) under fasting and in the last treatment period with 100 mg drinking solution (T2) under fed condition. There was washout period of 7days between the respective treatments.'}, {'id': 'BG011', 'title': 'T1/T2/R1/R2 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning. First they were treated with 100mg film coated tablet (T1) under fed condition, followed by 100 mg drinking solution (T2) under fed condition, 100mg film coated tablet (R1) under fasted condition and in the last treatment period with 100 mg drinking solution (R2) under fasting condition. There was a washout period of 7days between the respective treatments.'}, {'id': 'BG012', 'title': 'R2/R1/T2/T1 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (R2) under fasting condition, followed by 100mg film coated tablet (R1) under fasted condition,100 mg drinking solution (T2) under fed condition and in the last treatment period with 100mg film coated tablet (T1) under fed condition. There was washout period of 7days between the respective treatments.'}, {'id': 'BG013', 'title': 'T2/R2/T1/R1 (BA - Part)', 'description': 'Subjects were treated in each of the 4 treatment periods with one single oral dose in the morning, First they were treated with 100 mg drinking solution (T2) under fed condition, followed by 100 mg drinking solution (R2) under fasting, 100mg film coated tablet (T1) under fed condition and in the last treatment period with 100mg film coated tablet (R1) under fasted condition. There was washout period of 7days between the respective treatments.'}, {'id': 'BG014', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '39.5', 'spread': '7.3', 'groupId': 'BG003'}, {'value': '42.0', 'spread': '5.7', 'groupId': 'BG004'}, {'value': '39.7', 'spread': '8.0', 'groupId': 'BG005'}, {'value': '43.4', 'spread': '7.8', 'groupId': 'BG006'}, {'value': '35.7', 'spread': '9.2', 'groupId': 'BG007'}, {'value': '32.4', 'spread': '12.0', 'groupId': 'BG008'}, {'value': '35.9', 'spread': '7.2', 'groupId': 'BG009'}, {'value': '32.7', 'spread': '12.4', 'groupId': 'BG010'}, {'value': '27.0', 'spread': '3.6', 'groupId': 'BG011'}, {'value': '26.7', 'spread': '4.9', 'groupId': 'BG012'}, {'value': '27.0', 'spread': '5.6', 'groupId': 'BG013'}, {'value': '36.3', 'spread': '8.2', 'groupId': 'BG014'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '80', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2013-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2013-01-07', 'resultsFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-14', 'studyFirstPostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Drug Related Adverse Events', 'timeFrame': 'From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.', 'description': 'Percentage of subjects with drug related adverse events.'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '-2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Maximum measured concentration of the analyte in plasma (Cmax).\n\nThe treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part.\n\nThe per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) included all subjects of the TS-BA who provided observations under the reference treatment (R1) or test treatment (T1) for at least one of the endpoints Cmax, AUC0-tz, or AUC0-inf,without experiencing emesis at or before two times median tmax and without important protocol violations (PVs) relevant to the statistical evaluation of pharmacokinetic (PK). The same definition applies for the analysis set PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1.'}, {'measure': 'Tmax (Time From Dosing to Maximum Measured Concentration)', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Time from dosing to maximum measured concentration (tmax).'}, {'measure': 'AUC0-inf', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).'}, {'measure': 'AUC0- tz', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0- tz).'}, {'measure': 't1/2 (Terminal Half-life of the Analyte in Plasma)', 'timeFrame': '-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing', 'description': 'Terminal half-life of the analyte in plasma (t1/2).'}, {'measure': 'f t1-t2 (SRD-Part)', 'timeFrame': '0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours', 'description': 'Fraction of analyte eliminated in urine from the time point t1 (0h) to time point t2 (72h) (f t1-t2).'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1\\. healthy male subjects\n\nExclusion criteria:\n\n1\\. Any relevant deviation from healthy conditions'}, 'identificationModule': {'nctId': 'NCT01763333', 'briefTitle': 'To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1026706 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability of BI 1026706 (Open-label, Randomised, Four-way Cross-over)', 'orgStudyIdInfo': {'id': '1320.1'}, 'secondaryIdInfos': [{'id': '2012-002366-12', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 BI 1026706 single rising dose part', 'description': 'single rising doses of BI 1026706', 'interventionNames': ['Drug: BI 1026706 Placebo', 'Drug: BI 1026706']}, {'type': 'EXPERIMENTAL', 'label': '2 BI 1026706 bioavailability part', 'description': 'bioavailability part of BI 1026706', 'interventionNames': ['Drug: BI 1026706']}], 'interventions': [{'name': 'BI 1026706 Placebo', 'type': 'DRUG', 'description': 'Placebo to BI 1026706', 'armGroupLabels': ['1 BI 1026706 single rising dose part']}, {'name': 'BI 1026706', 'type': 'DRUG', 'description': 'different dose formulations', 'armGroupLabels': ['1 BI 1026706 single rising dose part', '2 BI 1026706 bioavailability part']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ingelheim', 'country': 'Germany', 'facility': '1320.1.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}