Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-03 @ 10:18 PM
Study NCT ID:
NCT02248259
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630656', 'term': 'BI 409306'}, {'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days', 'description': 'Adverse events were analysed by the treatment being administered at the time of the adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Extensive Metabolizers: Itra', 'description': 'Participants who were extensive metabolisers receiving only 2 capsules of 100 mg itraconazole (Itra) taken orally twice daily.', 'otherNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Extensive Metabolizers: BI 409306', 'description': 'Participants who were extensive metabolisers receiving only 1 single tablet of 25 mg BI 409306 taken orally.', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Extensive Metabolizers: Itra+BI 409306', 'description': 'Participants who were extensive metabolisers receiving 2 capsules of 100 mg itraconazole taken orally twice daily and 1 single tablet of 25 mg BI 409306 taken orally.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Poor Metabolizers: Itra', 'description': 'Participants who were poor metabolisers receiving only 2 capsules of 100 mg itraconazole taken orally twice daily.', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Poor Metabolizers: BI 409306', 'description': 'Participants who were poor metabolisers receiving only 1 single tablet of 25 mg BI 409306 taken orally.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Poor Metabolizers: Itra+BI 409306', 'description': 'Participants who were poor metabolisers receiving 2 capsules of 100 mg itraconazole taken orally twice daily and 1 single tablet of 25 mg BI 409306 taken orally.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, '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}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC0-infinity of BI 409306 and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extensive Metabolisers: Ref. Treatment', 'description': 'Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG001', 'title': 'Extensive Metabolisers: Test Treatment', 'description': 'Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}, {'id': 'OG002', 'title': 'Poor Metabolisers: Ref. Treatment', 'description': 'Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG003', 'title': 'Poor Metabolisers: Test Treatment', 'description': 'Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}], 'classes': [{'title': 'BI 409306', 'categories': [{'measurements': [{'value': '547', 'spread': '71.6', 'groupId': 'OG000'}, {'value': '621', 'spread': '68.8', 'groupId': 'OG001'}, {'value': '1560', 'spread': '45.5', 'groupId': 'OG002'}, {'value': '1370', 'spread': '39.4', 'groupId': 'OG003'}]}]}, {'title': 'CD 13896', 'categories': [{'measurements': [{'value': '389', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '347', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '178', 'spread': '20.0', 'groupId': 'OG002'}, {'value': '165', 'spread': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'CD 14084', 'categories': [{'measurements': [{'value': '2120', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '2110', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '1810', 'spread': '15.7', 'groupId': 'OG002'}, {'value': '1890', 'spread': '14.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.60', 'ciLowerLimit': '100.522', 'ciUpperLimit': '128.376', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.070', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for BI 409306', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.98', 'ciLowerLimit': '77.839', 'ciUpperLimit': '99.452', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.070', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for BI 409306', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.21', 'ciLowerLimit': '84.636', 'ciUpperLimit': '94.021', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.029', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 13896', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.89', 'ciLowerLimit': '88.592', 'ciUpperLimit': '97.396', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.026', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis of CD 13896', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.61', 'ciLowerLimit': '95.796', 'ciUpperLimit': '103.584', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.022', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 14084', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.37', 'ciLowerLimit': '98.783', 'ciUpperLimit': '110.278', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.031', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 14084', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084', 'unitOfMeasure': 'nanomole (nmol)*hour (h) /Liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS) which included all treated subjects who provided at least one evaluable primary or secondary endpoint in any of the study periods without important protocol violations with respect to the statistical evaluation of relative bioavailability.'}, {'type': 'PRIMARY', 'title': 'Cmax of BI 409306 and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extensive Metabolisers: Ref. Treatment', 'description': 'Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG001', 'title': 'Extensive Metabolisers: Test Treatment', 'description': 'Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}, {'id': 'OG002', 'title': 'Poor Metabolisers: Ref. Treatment', 'description': 'Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG003', 'title': 'Poor Metabolisers: Test Treatment', 'description': 'Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}], 'classes': [{'title': 'BI 409306', 'categories': [{'measurements': [{'value': '264', 'spread': '67.8', 'groupId': 'OG000'}, {'value': '246', 'spread': '60.2', 'groupId': 'OG001'}, {'value': '564', 'spread': '50.5', 'groupId': 'OG002'}, {'value': '432', 'spread': '35.4', 'groupId': 'OG003'}]}]}, {'title': 'CD 13896', 'categories': [{'measurements': [{'value': '139', 'spread': '41.6', 'groupId': 'OG000'}, {'value': '110', 'spread': '35.5', 'groupId': 'OG001'}, {'value': '44.9', 'spread': '33.3', 'groupId': 'OG002'}, {'value': '42.8', 'spread': '16.2', 'groupId': 'OG003'}]}]}, {'title': 'CD 14084', 'categories': [{'measurements': [{'value': '714', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '620', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '470', 'spread': '35.8', 'groupId': 'OG002'}, {'value': '505', 'spread': '20.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.26', 'ciLowerLimit': '80.377', 'ciUpperLimit': '108.217', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.086', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for BI 409306', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '76.65', 'ciLowerLimit': '60.482', 'ciUpperLimit': '97.141', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.140', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for BI 409306', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '78.71', 'ciLowerLimit': '67.304', 'ciUpperLimit': '92.052', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.090', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 13896', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.29', 'ciLowerLimit': '81.092', 'ciUpperLimit': '111.964', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.093', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 13896', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.79', 'ciLowerLimit': '80.731', 'ciUpperLimit': '93.309', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.041', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 14084', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.45', 'ciLowerLimit': '91.764', 'ciUpperLimit': '125.812', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.091', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 14084', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'SECONDARY', 'title': 'AUC0-tz of BI 409306 and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extensive Metabolisers: Ref. Treatment', 'description': 'Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG001', 'title': 'Extensive Metabolisers: Test Treatment', 'description': 'Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}, {'id': 'OG002', 'title': 'Poor Metabolisers: Ref. Treatment', 'description': 'Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG003', 'title': 'Poor Metabolisers: Test Treatment', 'description': 'Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}], 'classes': [{'title': 'BI 409306', 'categories': [{'measurements': [{'value': '546', 'spread': '71.6', 'groupId': 'OG000'}, {'value': '620', 'spread': '68.8', 'groupId': 'OG001'}, {'value': '1560', 'spread': '45.5', 'groupId': 'OG002'}, {'value': '1370', 'spread': '39.4', 'groupId': 'OG003'}]}]}, {'title': 'CD 13896', 'categories': [{'measurements': [{'value': '388', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '345', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '176', 'spread': '20.0', 'groupId': 'OG002'}, {'value': '163', 'spread': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'CD 14084', 'categories': [{'measurements': [{'value': '2120', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '2110', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '1810', 'spread': '15.7', 'groupId': 'OG002'}, {'value': '1890', 'spread': '14.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.61', 'ciLowerLimit': '100.505', 'ciUpperLimit': '128.427', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.070', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for BI 409306', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.91', 'ciLowerLimit': '77.763', 'ciUpperLimit': '99.370', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.070', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for BI 409306', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.05', 'ciLowerLimit': '84.478', 'ciUpperLimit': '93.859', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.029', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 13896', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.48', 'ciLowerLimit': '88.278', 'ciUpperLimit': '96.889', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.026', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 13896', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.61', 'ciLowerLimit': '95.791', 'ciUpperLimit': '103.583', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.022', 'estimateComment': 'Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 14084', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.44', 'ciLowerLimit': '98.861', 'ciUpperLimit': '110.336', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.031', 'estimateComment': 'Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment', 'groupDescription': 'Analysis for CD 14084', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence range was 80% to 125%'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', '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 plasma concentration (AUC0-tz) of BI 409306 and its metabolites CD 13896 and CD 14084', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'SECONDARY', 'title': 'Tmax of BI 409306 and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extensive Metabolisers: Ref. Treatment', 'description': 'Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG001', 'title': 'Extensive Metabolisers: Test Treatment', 'description': 'Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}, {'id': 'OG002', 'title': 'Poor Metabolisers: Ref. Treatment', 'description': 'Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG003', 'title': 'Poor Metabolisers: Test Treatment', 'description': 'Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}], 'classes': [{'title': 'BI 409306', 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '3.00'}, {'value': '1.75', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '4.02'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'CD 13896', 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.25', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '4.02'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '4.00'}]}]}, {'title': 'CD 14084', 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '4.02'}, {'value': '2.50', 'groupId': 'OG003', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Time from dosing to the maximum concentration of the analyte in plasma (tmax) of BI 409306 and its metabolites CD 13896 and CD 14084', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'SECONDARY', 'title': 't1/2 of BI 409306 and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Extensive Metabolisers: Ref. Treatment', 'description': 'Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG001', 'title': 'Extensive Metabolisers: Test Treatment', 'description': 'Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}, {'id': 'OG002', 'title': 'Poor Metabolisers: Ref. Treatment', 'description': 'Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)'}, {'id': 'OG003', 'title': 'Poor Metabolisers: Test Treatment', 'description': 'Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)'}], 'classes': [{'title': 'BI 409306', 'categories': [{'measurements': [{'value': '1.54', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '27.3', 'groupId': 'OG001'}, {'value': '2.87', 'spread': '64.1', 'groupId': 'OG002'}, {'value': '2.01', 'spread': '25.2', 'groupId': 'OG003'}]}]}, {'title': 'CD 13896', 'categories': [{'measurements': [{'value': '2.51', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '2.26', 'spread': '20.7', 'groupId': 'OG002'}, {'value': '2.17', 'spread': '16.8', 'groupId': 'OG003'}]}]}, {'title': 'CD 14084', 'categories': [{'measurements': [{'value': '3.13', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '3.21', 'spread': '39.9', 'groupId': 'OG002'}, {'value': '2.57', 'spread': '19.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Terminal half-life of the analyte in plasma (t1/2) of BI 409306 and its metabolites CD 13896 and CD 14084', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extensive Metabolisers: Ref / Test', 'description': 'Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:\n\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.'}, {'id': 'FG001', 'title': 'Poor Metabolisers: Ref / Test', 'description': 'Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:\n\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.'}, {'id': 'FG002', 'title': 'Extensive Metabolisers: Test / Ref', 'description': 'Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:\n\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).'}, {'id': 'FG003', 'title': 'Poor Metabolisers: Test / Ref', 'description': 'Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:\n\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A randomised, open-label, 2-way crossover trial.\n\nThe two treatment periods were separated by a washout period of at least 3 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Extensive Metabolisers', 'description': 'Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:\n\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.'}, {'id': 'BG001', 'title': 'Poor Metabolisers', 'description': 'Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:\n\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '8.36', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '6.53', 'groupId': 'BG001'}, {'value': '31.0', 'spread': '7.49', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set which included all subjects who received at least one dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2015-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2014-09-22', 'resultsFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2014-09-22', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-10', 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-infinity of BI 409306 and Its Metabolites', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084'}, {'measure': 'Cmax of BI 409306 and Its Metabolites', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084'}], 'secondaryOutcomes': [{'measure': 'AUC0-tz of BI 409306 and Its Metabolites', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', '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 plasma concentration (AUC0-tz) of BI 409306 and its metabolites CD 13896 and CD 14084'}, {'measure': 'Tmax of BI 409306 and Its Metabolites', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Time from dosing to the maximum concentration of the analyte in plasma (tmax) of BI 409306 and its metabolites CD 13896 and CD 14084'}, {'measure': 't1/2 of BI 409306 and Its Metabolites', 'timeFrame': '1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration', 'description': 'Terminal half-life of the analyte in plasma (t1/2) of BI 409306 and its metabolites CD 13896 and CD 14084'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Healthy CYP2C19 genotyped male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR, respiratory rate, body temperature), 12-lead ECG, ophthalmologic exam, clinical laboratory tests\n\n* Korean ethnicity according to the following criteria: be a current Korean passport or national identification card holder, and have parents and grandparents who were all born in Korea\n* Age 20 or older than 20 and 45 or younger than 45 years\n* BMI (Body Mass Index) 18.5 or more than 18.5 and BMI 25 or less than 25 kg/m2\n* Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.\n\nExclusion criteria:\n\n* Any finding of the medical examination (including BP, PR, respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance\n* Any evidence of a clinically relevant concomitant disease\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Surgery of the gastrointestinal tract (except appendectomy, hernia surgery)\n* Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month\n* History of relevant orthostatic hypotension, fainting spells or blackouts.\n* Chronic or relevant acute infections\n* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)\n* Intake of drugs with a long half-life (longer than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial\n* Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial\n* Participation in another trial with an investigational drug within two months prior to administration or during the trial\n* Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (more than 20 g/day)\n* Drug abuse\n* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)\n* Excessive physical activities (within one week prior to administration or during the trial)\n* Any laboratory value outside the reference range that is of clinical relevance\n* Inability to comply with dietary regimen of trial site\n* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval more than 450 ms)\n* A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n* Abnormality on color vision test or any other finding on ophthalmologic exam that is clinically deemed to potentially interfere with the safety assessment of this trial\n* Subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)'}, 'identificationModule': {'nctId': 'NCT02248259', 'briefTitle': 'Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Open-label, Randomised, Two-way Crossover Study to Assess the Effect of Once Daily Itraconazole on the Pharmacokinetics of BI 409306 After a Single Oral Dose in Healthy Male Volunteers Genotyped as Poor and Extensive Metabolizers of CYP2C19', 'orgStudyIdInfo': {'id': '1289.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extensive Metabolisers: Ref / Test', 'description': 'Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:\n\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.', 'interventionNames': ['Drug: BI 409306', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Poor Metabolisers: Ref / Test', 'description': 'Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:\n\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.', 'interventionNames': ['Drug: BI 409306', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Extensive Metabolisers: Test / Ref', 'description': 'Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:\n\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).', 'interventionNames': ['Drug: BI 409306', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Poor Metabolisers: Test / Ref', 'description': 'Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:\n\n* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.\n* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).', 'interventionNames': ['Drug: BI 409306', 'Drug: Itraconazole']}], 'interventions': [{'name': 'BI 409306', 'type': 'DRUG', 'description': 'Oral single dose of BI 409306', 'armGroupLabels': ['Extensive Metabolisers: Ref / Test', 'Extensive Metabolisers: Test / Ref', 'Poor Metabolisers: Ref / Test', 'Poor Metabolisers: Test / Ref']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole', 'armGroupLabels': ['Extensive Metabolisers: Ref / Test', 'Extensive Metabolisers: Test / Ref', 'Poor Metabolisers: Ref / Test', 'Poor Metabolisers: Test / Ref']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': '1289.23.8201 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}