Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT02057835
Status:
COMPLETED
Last Update Posted:
2015-12-16
First Post:
2014-02-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers
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': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From drug administration until 31 days after drug administration, 31 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BI 691751 5mg', 'description': 'Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BI 691751 10mg', 'description': 'Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BI 691751 30mg', 'description': 'Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'BI 691751 60mg', 'description': 'Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Drug Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese: Placebo', 'description': 'Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Japanese: Placebo', 'description': 'Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG008', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG009', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From drug administration until 31 days after drug administration, 31 days', 'description': 'Percentage of participants with drug related adverse events (AEs)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of the Analyte (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '175', 'spread': '45.7', 'groupId': 'OG000'}, {'value': '477', 'spread': '25.5', 'groupId': 'OG001'}, {'value': '1450', 'spread': '19.4', 'groupId': 'OG002'}, {'value': '3690', 'spread': '20.5', 'groupId': 'OG003'}, {'value': '129', 'spread': '33.2', 'groupId': 'OG004'}, {'value': '421', 'spread': '53.4', 'groupId': 'OG005'}, {'value': '1520', 'spread': '18.1', 'groupId': 'OG006'}, {'value': '4270', 'spread': '9.4', 'groupId': 'OG007'}]}]}, {'title': 'Blood', 'categories': [{'measurements': [{'value': '247', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '523', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '1490', 'spread': '22.1', 'groupId': 'OG002'}, {'value': '3470', 'spread': '16.4', 'groupId': 'OG003'}, {'value': '213', 'spread': '17.9', 'groupId': 'OG004'}, {'value': '509', 'spread': '35.4', 'groupId': 'OG005'}, {'value': '1530', 'spread': '22.4', 'groupId': 'OG006'}, {'value': '3600', 'spread': '12.4', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Maximum measured concentration of the analyte in plasma/whole blood', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of the Analyte (Cmax) - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 691751 5mg', 'description': 'Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 691751 10mg', 'description': 'Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 691751 30mg', 'description': 'Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 691751 60mg', 'description': 'Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '150', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '448', 'spread': '39.8', 'groupId': 'OG001'}, {'value': '1490', 'spread': '18.0', 'groupId': 'OG002'}, {'value': '3970', 'spread': '17.0', 'groupId': 'OG003'}]}]}, {'title': 'Blood', 'categories': [{'measurements': [{'value': '229', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '516', 'spread': '27.2', 'groupId': 'OG001'}, {'value': '1510', 'spread': '21.2', 'groupId': 'OG002'}, {'value': '3530', 'spread': '14.0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '0.333', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.667', 'groupId': 'OG001', 'lowerLimit': '0.333', 'upperLimit': '2.000'}, {'value': '0.667', 'groupId': 'OG002', 'lowerLimit': '0.333', 'upperLimit': '1.000'}, {'value': '0.667', 'groupId': 'OG003', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.667', 'groupId': 'OG004', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.500', 'groupId': 'OG005', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.667', 'groupId': 'OG006', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.667', 'groupId': 'OG007', 'lowerLimit': '0.333', 'upperLimit': '0.683'}]}]}, {'title': 'Blood', 'categories': [{'measurements': [{'value': '0.333', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '2.000'}, {'value': '0.667', 'groupId': 'OG001', 'lowerLimit': '0.333', 'upperLimit': '2.000'}, {'value': '0.667', 'groupId': 'OG002', 'lowerLimit': '0.333', 'upperLimit': '1.000'}, {'value': '0.667', 'groupId': 'OG003', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.500', 'groupId': 'OG004', 'lowerLimit': '0.333', 'upperLimit': '4.000'}, {'value': '0.333', 'groupId': 'OG005', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.667', 'groupId': 'OG006', 'lowerLimit': '0.333', 'upperLimit': '1.000'}, {'value': '0.667', 'groupId': 'OG007', 'lowerLimit': '0.333', 'upperLimit': '0.683'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 691751 5mg', 'description': 'Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 691751 10mg', 'description': 'Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 691751 30mg', 'description': 'Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 691751 60mg', 'description': 'Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '0.500', 'spread': '41.4', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '0.667'}, {'value': '0.667', 'spread': '39.8', 'groupId': 'OG001', 'lowerLimit': '0.333', 'upperLimit': '2.000'}, {'value': '0.667', 'spread': '18.0', 'groupId': 'OG002', 'lowerLimit': '0.333', 'upperLimit': '1.000'}, {'value': '0.667', 'spread': '17.0', 'groupId': 'OG003', 'lowerLimit': '0.333', 'upperLimit': '0.683'}]}]}, {'title': 'Blood', 'categories': [{'measurements': [{'value': '0.333', 'spread': '20.4', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '4.000'}, {'value': '0.500', 'spread': '27.2', 'groupId': 'OG001', 'lowerLimit': '0.333', 'upperLimit': '2.000'}, {'value': '0.667', 'spread': '21.2', 'groupId': 'OG002', 'lowerLimit': '0.333', 'upperLimit': '1.000'}, {'value': '0.667', 'spread': '14.0', 'groupId': 'OG003', 'lowerLimit': '0.333', 'upperLimit': '0.683'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma (N=0,5,6,6,0,0,6,6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.', 'groupId': 'OG000'}, {'value': '5280', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '18000', 'spread': '22.3', 'groupId': 'OG002'}, {'value': '37400', 'spread': '23.9', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated, since, according to internal rules, descriptive statistics were considered as reliable only when data from at least 2/3 of the subjects were available.', 'groupId': 'OG005'}, {'value': '22400', 'spread': '28.0', 'groupId': 'OG006'}, {'value': '42000', 'spread': '14.1', 'groupId': 'OG007'}]}]}, {'title': 'Blood (N=5,6,6,6,6,6,6,6)', 'categories': [{'measurements': [{'value': '31600', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '51800', 'spread': '22.4', 'groupId': 'OG001'}, {'value': '75600', 'spread': '13.5', 'groupId': 'OG002'}, {'value': '118000', 'spread': '10.3', 'groupId': 'OG003'}, {'value': '35600', 'spread': '65.5', 'groupId': 'OG004'}, {'value': '48700', 'spread': '19.6', 'groupId': 'OG005'}, {'value': '91800', 'spread': '38.6', 'groupId': 'OG006'}, {'value': '105000', 'spread': '11.4', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 691751 5mg', 'description': 'Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 691751 10mg', 'description': 'Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 691751 30mg', 'description': 'Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 691751 60mg', 'description': 'Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma (N=0, 8, 12, 12)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.', 'groupId': 'OG000'}, {'value': '5210', 'spread': '27.8', 'groupId': 'OG001'}, {'value': '20100', 'spread': '26.8', 'groupId': 'OG002'}, {'value': '39600', 'spread': '19.6', 'groupId': 'OG003'}]}]}, {'title': 'Blood (N=11, 12, 12, 12)', 'categories': [{'measurements': [{'value': '33800', 'spread': '47.5', 'groupId': 'OG000'}, {'value': '50200', 'spread': '20.4', 'groupId': 'OG001'}, {'value': '83300', 'spread': '29.2', 'groupId': 'OG002'}, {'value': '112000', 'spread': '12.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '1320', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '4720', 'spread': '17.8', 'groupId': 'OG001'}, {'value': '17500', 'spread': '23.1', 'groupId': 'OG002'}, {'value': '37000', 'spread': '24.2', 'groupId': 'OG003'}, {'value': '1310', 'spread': '27.3', 'groupId': 'OG004'}, {'value': '5060', 'spread': '38.7', 'groupId': 'OG005'}, {'value': '21600', 'spread': '28.6', 'groupId': 'OG006'}, {'value': '41100', 'spread': '13.8', 'groupId': 'OG007'}]}]}, {'title': 'Blood', 'categories': [{'measurements': [{'value': '19200', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '27900', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '41000', 'spread': '14.6', 'groupId': 'OG002'}, {'value': '66600', 'spread': '14.2', 'groupId': 'OG003'}, {'value': '19500', 'spread': '22.2', 'groupId': 'OG004'}, {'value': '29600', 'spread': '11.1', 'groupId': 'OG005'}, {'value': '48300', 'spread': '16.2', 'groupId': 'OG006'}, {'value': '66800', 'spread': '9.5', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood 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': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 691751 5mg', 'description': 'Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 691751 10mg', 'description': 'Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 691751 30mg', 'description': 'Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 691751 60mg', 'description': 'Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma (N=10, 12, 12, 12)', 'categories': [{'measurements': [{'value': '1310', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '4890', 'spread': '28.7', 'groupId': 'OG001'}, {'value': '19500', 'spread': '27.2', 'groupId': 'OG002'}, {'value': '39000', 'spread': '19.6', 'groupId': 'OG003'}]}]}, {'title': 'Blood (N=10, 12, 12, 12)', 'categories': [{'measurements': [{'value': '19400', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '28700', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '44500', 'spread': '17.1', 'groupId': 'OG002'}, {'value': '66700', 'spread': '11.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life of the Analyte (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG004', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG005', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG006', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG007', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma (N=0,5,6,6,0,0,6,6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.', 'groupId': 'OG000'}, {'value': '94.6', 'spread': '29.8', 'groupId': 'OG001'}, {'value': '102', 'spread': '34.3', 'groupId': 'OG002'}, {'value': '73.5', 'spread': '40.4', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.', 'groupId': 'OG005'}, {'value': '95.0', 'spread': '64.7', 'groupId': 'OG006'}, {'value': '89.9', 'spread': '26.2', 'groupId': 'OG007'}]}]}, {'title': 'Blood (N=5,6,6,6,6,6,6,6)', 'categories': [{'measurements': [{'value': '243', 'spread': '40.6', 'groupId': 'OG000'}, {'value': '333', 'spread': '30.6', 'groupId': 'OG001'}, {'value': '393', 'spread': '23.1', 'groupId': 'OG002'}, {'value': '417', 'spread': '23.7', 'groupId': 'OG003'}, {'value': '290', 'spread': '62.8', 'groupId': 'OG004'}, {'value': '265', 'spread': '26.2', 'groupId': 'OG005'}, {'value': '403', 'spread': '48.9', 'groupId': 'OG006'}, {'value': '340', 'spread': '26.0', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Terminal half-life (T1/2) of the analyte in plasma/whole blood', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life of the Analyte (T1/2) - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 691751 5mg', 'description': 'Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'BI 691751 10mg', 'description': 'Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'BI 691751 30mg', 'description': 'Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'BI 691751 60mg', 'description': 'Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'classes': [{'title': 'Plasma (N=0, 8, 12, 12)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.', 'groupId': 'OG000'}, {'value': '84.2', 'spread': '28.9', 'groupId': 'OG001'}, {'value': '98.4', 'spread': '48.4', 'groupId': 'OG002'}, {'value': '81.3', 'spread': '34.1', 'groupId': 'OG003'}]}]}, {'title': 'Blood (N=11, 12, 12, 12)', 'categories': [{'measurements': [{'value': '267', 'spread': '51.6', 'groupId': 'OG000'}, {'value': '297', 'spread': '29.8', 'groupId': 'OG001'}, {'value': '398', 'spread': '35.9', 'groupId': 'OG002'}, {'value': '377', 'spread': '26.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chinese: Placebo', 'description': 'Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG001', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG002', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG003', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG004', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG005', 'title': 'Japanese: Placebo', 'description': 'Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG006', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG007', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG008', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'FG009', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'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'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '64', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Chinese: Placebo', 'description': 'Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG001', 'title': 'Chinese: BI 691751 5mg', 'description': 'Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG002', 'title': 'Chinese: BI 691751 10mg', 'description': 'Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG003', 'title': 'Chinese: BI 691751 30mg', 'description': 'Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG004', 'title': 'Chinese: BI 691751 60mg', 'description': 'Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG005', 'title': 'Japanese: Placebo', 'description': 'Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG006', 'title': 'Japanese: BI 691751 5mg', 'description': 'Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG007', 'title': 'Japanese: BI 691751 10mg', 'description': 'Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG008', 'title': 'Japanese: BI 691751 30mg', 'description': 'Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG009', 'title': 'Japanese: BI 691751 60mg', 'description': 'Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '5.06', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '3.73', 'groupId': 'BG001'}, {'value': '23.0', 'spread': '2.53', 'groupId': 'BG002'}, {'value': '26.3', 'spread': '4.55', 'groupId': 'BG003'}, {'value': '28.8', 'spread': '4.02', 'groupId': 'BG004'}, {'value': '29.5', 'spread': '3.82', 'groupId': 'BG005'}, {'value': '31.7', 'spread': '4.76', 'groupId': 'BG006'}, {'value': '36.5', 'spread': '2.74', 'groupId': 'BG007'}, {'value': '31.0', 'spread': '4.82', 'groupId': 'BG008'}, {'value': '34.5', 'spread': '0.84', 'groupId': 'BG009'}, {'value': '29.0', 'spread': '5.52', 'groupId': 'BG010'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '64', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set which included all subjects who were documented to have taken study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-11', 'studyFirstSubmitDate': '2014-02-06', 'resultsFirstSubmitDate': '2015-11-11', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-11', 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Drug Related Adverse Events', 'timeFrame': 'From drug administration until 31 days after drug administration, 31 days', 'description': 'Percentage of participants with drug related adverse events (AEs)'}], 'secondaryOutcomes': [{'measure': 'Maximum Measured Concentration of the Analyte (Cmax)', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Maximum measured concentration of the analyte in plasma/whole blood'}, {'measure': 'Maximum Measured Concentration of the Analyte (Cmax) - Overall', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)'}, {'measure': 'Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax)', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood'}, {'measure': 'Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)'}, {'measure': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)'}, {'measure': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)'}, {'measure': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)'}, {'measure': 'Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)'}, {'measure': 'Terminal Half-life of the Analyte (T1/2)', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Terminal half-life (T1/2) of the analyte in plasma/whole blood'}, {'measure': 'Terminal Half-life of the Analyte (T1/2) - Overall', 'timeFrame': '1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration', 'description': 'Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'BI 691751 is currently being developed to inhibit growth and prevent rupture of atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and Japanese male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests\n2. Chinese ethnicity, Japanese ethnicity according to the following criteria:\n\n Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China Japanese; born in Japan and holding Japanese passport, have lived outside of Japan \\<10 years, and have parents and grandparents who were all born in Japan\n3. Age within the range of 20 to 45 years\n4. Body mass index within the range of 18.5 and 25 kg/m2\n5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.\n\nExclusion criteria:\n\n1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.\n2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n3. Any evidence of a concomitant disease judged clinically relevant by the investigator\n4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n5. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug\n6. Diseases of the central nervous system (such as epilepsy), central neurological disorders or psychiatric disorders\n7. History of relevant orthostatic hypotension, fainting spells, or blackouts\n8. Relevant chronic or acute infections\n9. History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)\n10. Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to study drug administration\n11. Use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval within 14 days prior to study drug administration\n12. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication\n13. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)\n14. Inability to refrain from smoking on specified trial days\n15. Alcohol abuse (consumption of more than30 g/day)\n16. Drug abuse or positive drug screen\n17. Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)\n18. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial\n19. Inability to comply with dietary regimen of trial site\n20. A marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTc interval greater than 450 ms) or any other relevant ECG finding\n21. A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)\n22. Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study.'}, 'identificationModule': {'nctId': 'NCT02057835', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers in a Randomised, Double-blind, Placebo-controlled Design.', 'orgStudyIdInfo': {'id': '1334.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 691751 low dose 1', 'description': 'BI 691751 low dose 1', 'interventionNames': ['Drug: Placebo to BI 691751', 'Drug: BI 691751 low dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'BI 691751 low dose 2', 'description': 'BI 691751 low dose 2', 'interventionNames': ['Drug: Placebo to BI 691751', 'Drug: BI 691751 low dose 2']}, {'type': 'EXPERIMENTAL', 'label': 'BI 691751 middle dose', 'description': 'BI 691751 middle dose', 'interventionNames': ['Drug: BI 691751 middle dose', 'Drug: Placebo to BI 691751']}, {'type': 'EXPERIMENTAL', 'label': 'BI 691751 high dose', 'description': 'BI 691751 high dose', 'interventionNames': ['Drug: Placebo to BI 691751', 'Drug: BI 691751 high dose']}], 'interventions': [{'name': 'Placebo to BI 691751', 'type': 'DRUG', 'description': 'Placebo to BI 691751', 'armGroupLabels': ['BI 691751 high dose']}, {'name': 'BI 691751 high dose', 'type': 'DRUG', 'description': 'BI 691751 high dose', 'armGroupLabels': ['BI 691751 high dose']}, {'name': 'BI 691751 middle dose', 'type': 'DRUG', 'description': 'BI 691751 middle dose', 'armGroupLabels': ['BI 691751 middle dose']}, {'name': 'Placebo to BI 691751', 'type': 'DRUG', 'description': 'Placebo to BI 691751', 'armGroupLabels': ['BI 691751 low dose 1']}, {'name': 'BI 691751 low dose 1', 'type': 'DRUG', 'description': 'BI 691751 low dose 1', 'armGroupLabels': ['BI 691751 low dose 1']}, {'name': 'Placebo to BI 691751', 'type': 'DRUG', 'description': 'Placebo to BI 691751', 'armGroupLabels': ['BI 691751 low dose 2']}, {'name': 'Placebo to BI 691751', 'type': 'DRUG', 'description': 'Placebo to BI 691751', 'armGroupLabels': ['BI 691751 middle dose']}, {'name': 'BI 691751 low dose 2', 'type': 'DRUG', 'description': 'BI 691751 low dose 2', 'armGroupLabels': ['BI 691751 low dose 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': '1334.5.82001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}