Viewing Study NCT01371006

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Ignite Creation Date: 2025-12-26 @ 4:02 PM
Ignite Modification Date: 2025-12-30 @ 5:47 AM
Study NCT ID: NCT01371006
Status: COMPLETED
Last Update Posted: 2015-08-03
First Post: 2011-06-09
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003276', 'term': 'Contraceptives, Oral'}], 'ancestors': [{'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, '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 Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24', 'description': 'AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: Efavirenz', 'description': 'Treatment with single-dose Efavirenz in Group A.', 'otherNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group A: Faldaprevir', 'description': 'During treatment with Faldaprevir in Group A.', 'otherNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group A: Faldaprevir+Efavirenz', 'description': 'During treatment with Faldaprevir and single-dose Efavirenz in Group A.', 'otherNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group B: Midazolam', 'description': 'Treatment with single-dose Midazolam in Group B.', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group B: Faldaprevir', 'description': 'During treatment with Faldaprevir in Group B.', 'otherNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group B: Faldaprevir+Midazolam', 'description': 'During treatment with Faldaprevir and single-dose Midazolam in Group B.', 'otherNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Group B: Faldaprevir+Midazolam+Efavirenz', 'description': 'During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Hypnagogic hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Circadian rhythm sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Rash maculo?papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Renal pain', 'stats': [{'groupId': 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13, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Group A - Efavirenz: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Efavirenz', 'description': 'single oral administration of 50 mg Efavirenz dosed alone (Day 1)'}, {'id': 'OG001', 'title': '50 mg Efavirenz+240 mg Faldaprevir', 'description': 'single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)'}], 'classes': [{'categories': [{'measurements': [{'value': '771.0', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '809.0', 'spread': '19.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.61', 'ciLowerLimit': '90.81', 'ciUpperLimit': '122.82', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '22.0', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz', 'description': 'Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.'}, {'type': 'PRIMARY', 'title': 'Group A - Efavirenz: AUC0-∞', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Efavirenz', 'description': 'single oral administration of 50 mg Efavirenz dosed alone (Day 1)'}, {'id': 'OG001', 'title': '50 mg Efavirenz+240 mg Faldaprevir', 'description': 'single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)'}], 'classes': [{'categories': [{'measurements': [{'value': '36100.0', 'spread': '30.3', 'groupId': 'OG000'}, {'value': '40700.0', 'spread': '28.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '116.12', 'ciLowerLimit': '101.87', 'ciUpperLimit': '132.35', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.8', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group A of the PK set.'}, {'type': 'PRIMARY', 'title': 'Group B - Faldaprevir: Cmax,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mg Midazolam+240 mg Faldaprevir', 'description': 'single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)'}, {'id': 'OG001', 'title': '7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz', 'description': 'single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)'}], 'classes': [{'categories': [{'measurements': [{'value': '24000.0', 'spread': '76.4', 'groupId': 'OG000'}, {'value': '17200.0', 'spread': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '71.83', 'ciLowerLimit': '61.46', 'ciUpperLimit': '83.95', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '23.6', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir', 'description': 'Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group B of the PK set.'}, {'type': 'PRIMARY', 'title': 'Group B - Faldaprevir: AUC0-12h,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mg Midazolam+240 mg Faldaprevir', 'description': 'single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)'}, {'id': 'OG001', 'title': '7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz', 'description': 'single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)'}], 'classes': [{'categories': [{'measurements': [{'value': '225000.0', 'spread': '91.1', 'groupId': 'OG000'}, {'value': '146000.0', 'spread': '148', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '64.97', 'ciLowerLimit': '53.32', 'ciUpperLimit': '79.16', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '30.2', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir', 'description': 'Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group B of the PK set.'}, {'type': 'PRIMARY', 'title': 'Group B - Faldaprevir: C12,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7.5 mg Midazolam+240 mg Faldaprevir', 'description': 'single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)'}, {'id': 'OG001', 'title': '7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz', 'description': 'single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)'}], 'classes': [{'categories': [{'measurements': [{'value': '14700.0', 'spread': '119.0', 'groupId': 'OG000'}, {'value': '7650.0', 'spread': '277.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '54.31', 'ciLowerLimit': '40.47', 'ciUpperLimit': '72.88', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '44.2', 'estimateComment': 'the standard deviation is actually the geometric coefficient of variation', 'groupDescription': 'relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'investigation of relative bioavailability (no formal testing)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir', 'description': 'Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group B of the PK set.'}, {'type': 'SECONDARY', 'title': 'Group A - Faldaprevir: Cmax,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}], 'classes': [{'categories': [{'measurements': [{'value': '34600.0', 'spread': '26.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients entered in sequence group A of the PK set'}, {'type': 'SECONDARY', 'title': 'Group A - Faldaprevir: Tmax,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'spread': '0.836', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients entered in sequence sequence group A of the PK set'}, {'type': 'SECONDARY', 'title': 'Group A - Faldaprevir: AUC0-12h,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}], 'classes': [{'categories': [{'measurements': [{'value': '341000', 'spread': '27.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients entered in sequence group A of the PK set'}, {'type': 'SECONDARY', 'title': 'Group A - Faldaprevir: C12,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}], 'classes': [{'categories': [{'measurements': [{'value': '23900', 'spread': '27.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients entered in sequence group A of the PK set'}, {'type': 'SECONDARY', 'title': 'Group A - Efavirenz: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}], 'classes': [{'title': 'Day 1: Efavirenz', 'categories': [{'measurements': [{'value': '3.00', 'spread': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '4.02'}]}]}, {'title': 'Day 14: Efavirenz+Faldaprevir (N=13)', 'categories': [{'measurements': [{'value': '3.03', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz', 'description': 'Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients entered in sequence group A of the PK set'}, {'type': 'SECONDARY', 'title': 'Group B - Faldaprevir: Tmax,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.\n\nEfavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.\n\noral administration with water after food intake.'}], 'classes': [{'title': 'Day 9: Midazolam+Faldaprevir', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.17'}]}]}, {'title': 'Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)', 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients entered in sequence group B of the PK set'}, {'type': 'SECONDARY', 'title': 'Group B - Midazolam: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.\n\noral administration with water after food intake.'}], 'classes': [{'title': 'Day 1: Midazolam', 'categories': [{'measurements': [{'value': '110.0', 'spread': '45.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 9: Midazolam+Faldaprevir', 'categories': [{'measurements': [{'value': '121.0', 'spread': '46.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)', 'categories': [{'measurements': [{'value': '44.9', 'spread': '101.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam', 'description': 'Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group B of the PK set.'}, {'type': 'SECONDARY', 'title': 'Group B - Midazolam: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.\n\noral administration with water after food intake.'}], 'classes': [{'title': 'Day 1: Midazolam', 'categories': [{'measurements': [{'value': '1.00', 'spread': '47.0', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.50'}]}]}, {'title': 'Day 9: Midazolam+Faldaprevir', 'categories': [{'measurements': [{'value': '1.00', 'spread': '59.7', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '3.00'}]}]}, {'title': 'Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)', 'categories': [{'measurements': [{'value': '0.74', 'spread': '59.0', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '3.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam', 'description': 'Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group B of the PK set.'}, {'type': 'SECONDARY', 'title': 'Group B - Midazolam: AUC0-∞', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.\n\noral administration with water after food intake.'}], 'classes': [{'title': 'Day 1: Midazolam', 'categories': [{'measurements': [{'value': '278', 'spread': '28.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 9: Midazolam+Faldaprevir', 'categories': [{'measurements': [{'value': '624', 'spread': '54.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)', 'categories': [{'measurements': [{'value': '110', 'spread': '88.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam', 'description': 'Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group B of the PK set.'}, {'type': 'SECONDARY', 'title': 'Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}, {'id': 'OG001', 'title': 'Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.\n\nEfavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.\n\noral administration with water after food intake.'}], 'classes': [{'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hepatic enzyme increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment administration (Day 1) up to Day 24', 'description': 'Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication'}, {'type': 'SECONDARY', 'title': 'Group A - Number of Participants With Drug Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Efavirenz', 'description': 'Treatment with single-dose Efavirenz.'}, {'id': 'OG001', 'title': 'Faldaprevir', 'description': 'During treatment with Faldaprevir.'}, {'id': 'OG002', 'title': 'Efavirenz+Faldaprevir', 'description': 'During treatment with Faldaprevir and single-dose Efavirenz.'}, {'id': 'OG003', 'title': 'Total On-treatment', 'description': 'Total number of participants with drug related adverse events during treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)', 'description': 'Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.\n\nAEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group A of the treated set.'}, {'type': 'SECONDARY', 'title': 'Group B - Number of Participants With Drug Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'Treatment with single-dose Midazolam.'}, {'id': 'OG001', 'title': 'Faldaprevir', 'description': 'During treatment with Faldaprevir.'}, {'id': 'OG002', 'title': 'Faldaprevir+Midazolam', 'description': 'During treatment with Faldaprevir and single-dose Midazolam.'}, {'id': 'OG003', 'title': 'Faldaprevir+Midazolam+Efavirenz', 'description': 'During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam'}, {'id': 'OG004', 'title': 'Total On-treatment', 'description': 'Total number of participants with drug related adverse events during treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)', 'description': 'Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.\n\nAEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects entered in sequence group B of the treated set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}, {'id': 'FG001', 'title': 'Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.\n\nEfavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.\n\noral administration with water after food intake.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: 240 mg Faldaprevir+50 mg Efavirenz', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.\n\nEfavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.\n\noral administration with water after food intake.'}, {'id': 'BG001', 'title': 'Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam', 'description': 'Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.\n\nEfavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.\n\noral administration with water after food intake.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '36.1', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-03', 'studyFirstSubmitDate': '2011-06-09', 'resultsFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-03', 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group A - Efavirenz: Cmax', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz', 'description': 'Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)'}, {'measure': 'Group A - Efavirenz: AUC0-∞', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)'}, {'measure': 'Group B - Faldaprevir: Cmax,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir', 'description': 'Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)'}, {'measure': 'Group B - Faldaprevir: AUC0-12h,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir', 'description': 'Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)'}, {'measure': 'Group B - Faldaprevir: C12,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir', 'description': 'Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)'}], 'secondaryOutcomes': [{'measure': 'Group A - Faldaprevir: Cmax,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)'}, {'measure': 'Group A - Faldaprevir: Tmax,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)'}, {'measure': 'Group A - Faldaprevir: AUC0-12h,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)'}, {'measure': 'Group A - Faldaprevir: C12,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)'}, {'measure': 'Group A - Efavirenz: Tmax', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz', 'description': 'Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)'}, {'measure': 'Group B - Faldaprevir: Tmax,ss', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir', 'description': 'Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)'}, {'measure': 'Group B - Midazolam: Cmax', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam', 'description': 'Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)'}, {'measure': 'Group B - Midazolam: Tmax', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam', 'description': 'Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)'}, {'measure': 'Group B - Midazolam: AUC0-∞', 'timeFrame': '0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam', 'description': 'Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)'}, {'measure': 'Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG', 'timeFrame': 'From first treatment administration (Day 1) up to Day 24', 'description': 'Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.'}, {'measure': 'Group A - Number of Participants With Drug Related Adverse Events', 'timeFrame': 'From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)', 'description': 'Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.\n\nAEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.'}, {'measure': 'Group B - Number of Participants With Drug Related Adverse Events', 'timeFrame': 'From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)', 'description': 'Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.\n\nAEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.\n\nTo predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nHealthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9\n\nExclusion criteria:\n\n1. Any finding on medical examination and ECG (Electrocardiography) deviating from normal\n2. Active diseases\n3. History of photosensitivity or rash'}, 'identificationModule': {'nctId': 'NCT01371006', 'briefTitle': 'Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Effect of Multiple Dosing With 240mg q 12hrs BI 201335 on the Pharmacokinetics of 50 mg Single Dose Efavirenz and Effect of Multiple Dosing With 600mg QD Efavirenz on Cyp 3A4 and the Pharmacokinetics of BI 201335 in Healthy Volunteers', 'orgStudyIdInfo': {'id': '1220.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI201335 low dose Efavirenz', 'description': 'low dose Efavirenz', 'interventionNames': ['Drug: low dose']}, {'type': 'EXPERIMENTAL', 'label': 'BI201335 high dose Efavirenz', 'description': 'normal dose Efavirenz', 'interventionNames': ['Drug: low dose', 'Drug: normal dose']}], 'interventions': [{'name': 'low dose', 'type': 'DRUG', 'description': 'efavirenz single dosing once daily', 'armGroupLabels': ['BI201335 high dose Efavirenz']}, {'name': 'normal dose', 'type': 'DRUG', 'description': 'efavirenz once daily', 'armGroupLabels': ['BI201335 high dose Efavirenz']}, {'name': 'low dose', 'type': 'DRUG', 'description': 'Efavirenz single dosing once daily', 'armGroupLabels': ['BI201335 low dose Efavirenz']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': '1220.20.41001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}