Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 7:14 AM
Study NCT ID:
NCT01632566
Status:
TERMINATED
Last Update Posted:
2019-06-27
First Post:
2012-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multiple-dose Study of LY3031207 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627901', 'term': 'LY3031207'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Lilly voluntarily discontinued dosing of LY3031207 for all participants in LBCB because of early discontinuation criteria being met. Data for some endpoints (including blood pressure and Japanese comparison) were incomplete for the planned analyses.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo With or Without Simvastatin', 'description': 'Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.', 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': '400 mg Celecoxib With or Without Simvastatin', 'description': 'Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '10 mg Simvastatin', 'description': 'Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.', 'otherNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sensitivity of teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'OG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}, {'id': 'OG003', 'title': 'Placebo With or Without Simvastatin', 'description': 'Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG004', 'title': '400 mg Celecoxib With or Without Simvastatin', 'description': 'Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG005', 'title': '10 mg Simvastatin', 'description': 'Oral administration of 10 mg open-label simvastatin on Days -3 and 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207 (Day -3 only), placebo, or celecoxib. Adverse events occurring following simvastatin dosing on Day -3 but prior to study drug dosing on Day 1 were counted under simvastatin.'}], 'classes': [{'title': 'Participants with one or more AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Participants with one or more serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to study completion (treatment completion and follow-up, up to 35 weeks)', 'description': 'A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities.\n\nA summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'OG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}], 'classes': [{'categories': [{'measurements': [{'value': '1120', 'spread': '34.3', 'groupId': 'OG000'}, {'value': '2290', 'spread': '42.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose up to 48 hours post last dose at Day 28', 'description': 'Maximum concentration (Cmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.', 'unitOfMeasure': 'nanograms/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of LY3031207 with evaluable Cmax data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'OG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}], 'classes': [{'categories': [{'measurements': [{'value': '12000', 'spread': '39.7', 'groupId': 'OG000'}, {'value': '30400', 'spread': '45.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose up to 48 hours post last dose at Day 28', 'description': 'Area under the concentration versus time curve in a dosing interval (AUC\\[0-tau\\]) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.', 'unitOfMeasure': 'nanograms*hours/milliliter (hr*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of LY3031207 with evaluable AUC (0-tau) data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'OG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '12.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose up to 48 hours post last dose at Day 28', 'description': 'Time of maximum concentration (Tmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of LY3031207 with evaluable Tmax data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Simvastatin Day -3', 'description': 'Oral administration of 10 mg open-label simvastatin on Day -3 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.'}, {'id': 'OG001', 'title': '10 mg Simvastatin Day 28', 'description': 'Oral administration of 10 mg open-label simvastatin on Day 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.78', 'spread': '55.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '69.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose up to 48 hours post dose at Day -3 and Day 28', 'unitOfMeasure': 'nanograms/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Simvastatin Day -3', 'description': 'Oral administration of 10 mg open-label simvastatin on Day -3 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.'}, {'id': 'OG001', 'title': '10 mg Simvastatin Day 28', 'description': 'Oral administration of 10 mg open-label simvastatin on Day 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.23', 'spread': '48.9', 'groupId': 'OG000'}, {'value': '8.97', 'spread': '70.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose up to 48 hours post dose at Day -3 and Day 28', 'description': 'Area under the concentration versus time curve over the range of all measureable concentrations (AUC\\[0-tlast\\]) of simvastatin.', 'unitOfMeasure': 'nanograms*hours/milliliter (hr*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Simvastatin Day -3', 'description': 'Oral administration of 10 mg open-label simvastatin on Day -3 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.'}, {'id': 'OG001', 'title': '10 mg Simvastatin Day 28', 'description': 'Oral administration of 10 mg open-label simvastatin on Day 28 for participants randomized to 75 mg LY3031207, 225 mg LY3031207, placebo, or celecoxib.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose up to 48 hours post dose at Day -3 and Day 28', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'OG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}], 'timeFrame': 'Baseline, Predose up to 12 hours prior to last dose at Day 28', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. Data not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'OG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}], 'timeFrame': 'Baseline, Predose up to time of last dose at Day 28', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. Data not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'OG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'OG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}], 'timeFrame': 'Baseline, Predose up to 12 hours prior to last dose at Day 28', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. Data not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'FG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'FG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}, {'id': 'FG003', 'title': 'Placebo With or Without Simvastatin', 'description': 'Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'FG004', 'title': '400 mg Celecoxib With or Without Simvastatin', 'description': 'Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Received at Least One Dose LY3031207', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose Simvastatin', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Study enrolled participants of both Japanese and non-Japanese decent. Participants were pooled regardless of ethnicity. Participants assigned to 75 milligrams (mg) LY3031207 and 225 mg LY3031207 underwent identical procedures as those assigned to 25 mg LY3031207 with the addition of 10 mg open-label simvastatin administration on Days -3 and 28.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '25 mg LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 for 28 days.'}, {'id': 'BG001', 'title': '75 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 for up to 28 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'BG002', 'title': '225 mg LY3031207 and Simvastatin', 'description': 'Daily oral administration of 225 mg LY3031207 for up to 22 days. In addition, participants received oral administration of 10 mg open-label simvastatin on Day -3 only.'}, {'id': 'BG003', 'title': 'Placebo With or Without Simvastatin', 'description': 'Daily oral administration of placebo for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'BG004', 'title': '400 mg Celecoxib With or Without Simvastatin', 'description': 'Daily oral administration of 400 mg celecoxib for up to 28 days with or without oral administration of 10 mg open-label simvastatin on Days -3 and 28.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '45.1', 'spread': '14.7', 'groupId': 'BG002'}, {'value': '52.7', 'spread': '5.8', 'groupId': 'BG003'}, {'value': '44.0', 'spread': '7.8', 'groupId': 'BG004'}, {'value': '43.0', 'spread': '11.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who received at least dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in some participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2012-06-25', 'resultsFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2012-07-02', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-18', 'studyFirstPostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs', 'timeFrame': 'Baseline to study completion (treatment completion and follow-up, up to 35 weeks)', 'description': 'A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities.\n\nA summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207', 'timeFrame': 'Predose up to 48 hours post last dose at Day 28', 'description': 'Maximum concentration (Cmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207', 'timeFrame': 'Predose up to 48 hours post last dose at Day 28', 'description': 'Area under the concentration versus time curve in a dosing interval (AUC\\[0-tau\\]) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.'}, {'measure': 'Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207', 'timeFrame': 'Predose up to 48 hours post last dose at Day 28', 'description': 'Time of maximum concentration (Tmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin', 'timeFrame': 'Predose up to 48 hours post dose at Day -3 and Day 28'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin', 'timeFrame': 'Predose up to 48 hours post dose at Day -3 and Day 28', 'description': 'Area under the concentration versus time curve over the range of all measureable concentrations (AUC\\[0-tlast\\]) of simvastatin.'}, {'measure': 'Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin', 'timeFrame': 'Predose up to 48 hours post dose at Day -3 and Day 28'}, {'measure': 'Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion', 'timeFrame': 'Baseline, Predose up to 12 hours prior to last dose at Day 28'}, {'measure': 'Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion', 'timeFrame': 'Baseline, Predose up to time of last dose at Day 28'}, {'measure': 'Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion', 'timeFrame': 'Baseline, Predose up to 12 hours prior to last dose at Day 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to healthy Japanese and non-Japanese participants as multiple doses. In addition, effects of 28-day oral dosing of LY3031207 on the amount of a cholesterol-lowering drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of it will be determined. The effects of LY3031207 after single and 28-day dosing on blood pressure will also be studied. Information about any side effects that may occur will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overtly healthy individuals based on the history and physical examinations as determined by the investigator, including first generation Japanese\n* Body mass index between 17.0 and 32.0 kilograms per square meter (kg/m\\^2), inclusive\n\nExclusion Criteria:\n\n* Have known allergies to LY3031207 or any components of the formulation, simvastatin or related compounds (other 3-Hydroxy-3-Methyl-Glutaryl-CoA \\[HMG CoA\\] reductase inhibitors), celecoxib, or sulfonamides. Participants with known aspirin allergy or allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded'}, 'identificationModule': {'nctId': 'NCT01632566', 'briefTitle': 'A Multiple-dose Study of LY3031207 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects', 'orgStudyIdInfo': {'id': '14284'}, 'secondaryIdInfos': [{'id': 'I5W-EW-LBCB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3031207', 'description': 'Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days.', 'interventionNames': ['Drug: LY3031207']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib', 'description': 'Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207.', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'OTHER', 'label': 'LY3031207 + Simvastatin', 'description': 'Daily oral administration of 75 mg LY3031207 or 225 mg LY3031207 for 28 days. Single, oral 10 mg simvastatin open-label dose administered before and after 28-day dosing of LY3031207.', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules administered orally', 'armGroupLabels': ['Placebo']}, {'name': 'LY3031207', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3031207']}, {'name': 'Celecoxib', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Celecoxib']}, {'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3031207 + Simvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], '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'}}}}