Viewing Study NCT02300259

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Ignite Creation Date: 2025-12-24 @ 2:42 PM
Ignite Modification Date: 2026-04-22 @ 11:18 PM
Study NCT ID: NCT02300259
Status: COMPLETED
Last Update Posted: 2020-06-26
First Post: 2014-11-20
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of LY2623091 in Healthy Participants
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': 'D017964', 'term': 'Itraconazole'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D004110', 'term': 'Diltiazem'}], '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'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.', 'eventGroups': [{'id': 'EG000', 'title': 'LY2623091 (Group 1)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Itraconazole (Group 1)', 'description': 'Period 2: Oral doses of 200 mg itraconazole BID on Days 1 through 5.', 'otherNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Itraconazole + LY2623091 (Group 1)', 'description': 'Period 2: Oral doses of 200 mg itraconazole and 6 mg LY2623091 coadministered once on Day 6.', 'otherNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Simvastatin (Group 2)', 'description': 'Single oral dose of 20 mg simvastatin on Day 1.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'LY2623091 (Group 2)', 'description': 'Oral doses of 24.5 mg LY2623091 QD on Days 3 to 11.', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'LY2623091 + Simvastatin (Group 2)', 'description': 'Oral doses of 24.5 mg LY2623091 and 20 mg simvastatin coadministered once on Day 12.', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'LY2623091 (Group 4)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.', 'otherNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Diltiazem (Group 4)', 'description': 'Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 through 3.', 'otherNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Diltiazem + LY2623091 (Group 4)', 'description': 'Period 2: Oral doses of 240 mg diltiazem extended release and 6 mg LY2623091 coadministered once on Day 4.', 'otherNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2623091 (Group 1)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.'}, {'id': 'OG001', 'title': 'Itraconazole + LY2623091 (Group 1)', 'description': 'Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.'}, {'id': 'OG002', 'title': 'LY2623091 (Group 4)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.\n\n.'}, {'id': 'OG003', 'title': 'Diltiazem + LY2623091 (Group 4)', 'description': 'Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '21', 'groupId': 'OG000'}, {'value': '66.9', 'spread': '27', 'groupId': 'OG001'}, {'value': '61.8', 'spread': '34', 'groupId': 'OG002'}, {'value': '64.2', 'spread': '30', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable Cmax results.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2623091 (Group 1)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.'}, {'id': 'OG001', 'title': 'Itraconazole + LY2623091 (Group 1)', 'description': 'Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.'}, {'id': 'OG002', 'title': 'LY2623091 (Group 4)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.'}, {'id': 'OG003', 'title': 'Diltiazem + LY2623091 (Group 4)', 'description': 'Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '2540', 'spread': '27', 'groupId': 'OG000'}, {'value': '5660', 'spread': '31', 'groupId': 'OG001'}, {'value': '2390', 'spread': '39', 'groupId': 'OG002'}, {'value': '3360', 'spread': '43', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose', 'unitOfMeasure': 'nanograms*hour/milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-infinity) results.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2623091 (Group 1)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.'}, {'id': 'OG001', 'title': 'Itraconazole + LY2623091 (Group 1)', 'description': 'Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.'}, {'id': 'OG002', 'title': 'LY2623091 (Group 4)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.'}, {'id': 'OG003', 'title': 'Diltiazem + LY2623091 (Group 4)', 'description': 'Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '2480', 'spread': '27', 'groupId': 'OG000'}, {'value': '5240', 'spread': '31', 'groupId': 'OG001'}, {'value': '2340', 'spread': '39', 'groupId': 'OG002'}, {'value': '3130', 'spread': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-tlast) results.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin (Group 2)', 'description': 'Single oral dose of 20 mg simvastatin on Day 1.'}, {'id': 'OG001', 'title': 'LY2623091 + Simvastatin (Group 2)', 'description': 'Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.'}], 'classes': [{'title': 'Simvastatin', 'categories': [{'measurements': [{'value': '7.78', 'spread': '63', 'groupId': 'OG000'}, {'value': '9.89', 'spread': '45', 'groupId': 'OG001'}]}]}, {'title': 'Simvastatin Acid', 'categories': [{'measurements': [{'value': '0.720', 'spread': '41', 'groupId': 'OG000'}, {'value': '0.877', 'spread': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Group 2 who received at least one dose of study drug and had evaluable Cmax results.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin (Group 2)', 'description': 'Single oral dose of 20 mg simvastatin on Day 1.'}, {'id': 'OG001', 'title': 'LY2623091 + Simvastatin', 'description': 'Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.'}], 'classes': [{'title': 'Simvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '48', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '34', 'groupId': 'OG001'}]}]}, {'title': 'Simvastatin Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.15', 'spread': '56', 'groupId': 'OG000'}, {'value': '8.88', 'spread': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-infinity) results.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin (Group 2)', 'description': 'Single oral dose of 20 mg simvastatin on Day 1.'}, {'id': 'OG001', 'title': 'LY2623091 + Simvastatin', 'description': 'Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.'}], 'classes': [{'title': 'Simvastatin', 'categories': [{'measurements': [{'value': '16.5', 'spread': '49', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '34', 'groupId': 'OG001'}]}]}, {'title': 'Simvastatin Acid', 'categories': [{'measurements': [{'value': '5.42', 'spread': '48', 'groupId': 'OG000'}, {'value': '6.87', 'spread': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-tlast) results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2623091 + Itraconazole (Group 1)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.\n\nPeriod 2: Oral doses of 200 mg itraconazole twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.'}, {'id': 'FG001', 'title': 'Simvastatin + LY2623091 (Group 2)', 'description': 'Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.'}, {'id': 'FG002', 'title': 'LY2623091 + Diltiazem (Group 4)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.\n\nPeriod 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'comment': 'There was no period 2 for Group 2.', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study planned to enroll 3 groups. After Groups 1 and 2 were enrolled, data from Group 2 were analyzed according to a pre-specified algorithm. Results met criteria to enroll Group 4. (Group 3 was not enrolled.)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2623091 + Itraconazole (Group 1)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.\n\nPeriod 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.'}, {'id': 'BG001', 'title': 'Simvastatin + LY2623091 (Group 2)', 'description': 'Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.'}, {'id': 'BG002', 'title': 'LY2623091 + Diltiazem (Group 4)', 'description': 'Period 1: Single oral dose of 6 mg LY2623091 on Day 1.\n\nPeriod 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '39.7', 'spread': '9.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2014-11-20', 'resultsFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-09', 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091', 'timeFrame': 'Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091', 'timeFrame': 'Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091', 'timeFrame': 'Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose'}, {'measure': 'Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid', 'timeFrame': 'Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid', 'timeFrame': 'Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid', 'timeFrame': 'Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The first purpose of this study is to evaluate the effect of itraconazole (and possibly diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get rid of it.\n\nThe second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.\n\nThe safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.\n\nThere will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants as determined by medical history, physical examination, clinical laboratory tests, and electrocardiograms (ECGs).\n* Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m\\^2) inclusive, at screening\n* Female participants must be of non-childbearing potential\n\nExclusion Criteria:\n\n* In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study'}, 'identificationModule': {'nctId': 'NCT02300259', 'briefTitle': 'A Study of LY2623091 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study to Determine the Effect of CYP3A Inhibition on the Pharmacokinetics of LY2623091 and the Effect of LY2623091 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects', 'orgStudyIdInfo': {'id': '15523'}, 'secondaryIdInfos': [{'id': 'I7T-MC-RMAG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2623091 (Group 1)', 'description': 'LY2623091 administered orally once on Day 1 of Period 1.', 'interventionNames': ['Drug: LY2623091']}, {'type': 'EXPERIMENTAL', 'label': 'Itraconazole + LY2623091 (Group 1)', 'description': '200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2.', 'interventionNames': ['Drug: LY2623091', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin (Group 2)', 'description': '20 mg simvastatin administered orally once daily on Day 1.', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'LY2623091 + Simvastatin (Group 2)', 'description': 'LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12.', 'interventionNames': ['Drug: LY2623091', 'Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Tadalafil (Group 3)', 'description': '5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'EXPERIMENTAL', 'label': 'Tadalafil + LY2623091 (Group 3)', 'description': 'LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2.', 'interventionNames': ['Drug: LY2623091', 'Drug: Tadalafil']}, {'type': 'EXPERIMENTAL', 'label': 'LY2623091 (Group 4)', 'description': 'LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.', 'interventionNames': ['Drug: LY2623091']}, {'type': 'EXPERIMENTAL', 'label': 'Diltiazem + LY2623091 (Group 4)', 'description': '240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2.', 'interventionNames': ['Drug: LY2623091', 'Drug: Diltiazem']}], 'interventions': [{'name': 'LY2623091', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Diltiazem + LY2623091 (Group 4)', 'Itraconazole + LY2623091 (Group 1)', 'LY2623091 (Group 1)', 'LY2623091 (Group 4)', 'LY2623091 + Simvastatin (Group 2)', 'Tadalafil + LY2623091 (Group 3)']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Itraconazole + LY2623091 (Group 1)']}, {'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY2623091 + Simvastatin (Group 2)', 'Simvastatin (Group 2)']}, {'name': 'Tadalafil', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Tadalafil (Group 3)', 'Tadalafil + LY2623091 (Group 3)']}, {'name': 'Diltiazem', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Diltiazem + LY2623091 (Group 4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}