Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT01536951
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2012-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of LY3009104 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Part A: Placebo', 'description': 'Placebo tablets \\[matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104\\] administered orally once in any period during Part A of the study.', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: 20 mg LY3009104', 'description': 'A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: 30 mg LY3009104', 'description': 'A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part B: Placebo', 'description': 'Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.', 'otherNumAtRisk': 52, 'otherNumAffected': 8, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part B: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.', 'otherNumAtRisk': 53, 'otherNumAffected': 6, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: Moxifloxacin', 'description': 'A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.', 'otherNumAtRisk': 53, 'otherNumAffected': 7, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, 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'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 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'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Increased upper airway secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.'}, {'id': 'OG001', 'title': 'Part B: 40 mg LY3009104', 'description': 'A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.'}, {'id': 'OG002', 'title': 'Part B: Moxifloxacin', 'description': 'A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.'}], 'classes': [{'title': '1 h postdose (n=52, 53, 53)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': '1.5 h postdose (n=52, 53, 53)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': '2 h postdose (n=52, 53, 53)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '6.9', 'groupId': 'OG002'}]}]}, {'title': '3 h postdose (n=52, 53, 53)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '6.2', 'groupId': 'OG002'}]}]}, {'title': '4 h postdose (n=52, 53, 53)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': '6 h postdose (n=51, 53, 53)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '7.3', 'groupId': 'OG002'}]}]}, {'title': '12 h postdose (n=52, 52, 52)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': '24 h postdose (n=52, 53, 53)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '5.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.239', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '2.12', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.81', 'ciLowerLimit': '-0.0790', 'ciUpperLimit': '3.69', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.44', 'ciLowerLimit': '-0.446', 'ciUpperLimit': '3.32', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.468', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '2.35', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.702', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '2.59', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.788', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '1.10', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.71', 'ciLowerLimit': '-0.182', 'ciUpperLimit': '3.60', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.963', 'ciLowerLimit': '-0.921', 'ciUpperLimit': '2.85', 'estimateComment': 'LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.3', 'ciLowerLimit': '10.0', 'ciUpperLimit': '14.5', 'estimateComment': 'LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.0', 'ciLowerLimit': '8.74', 'ciUpperLimit': '13.3', 'estimateComment': 'LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.1', 'ciLowerLimit': '8.87', 'ciUpperLimit': '13.4', 'estimateComment': 'LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose', 'description': 'The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR\\^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta\\*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period \\[-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h\\]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.', 'unitOfMeasure': 'milliseconds (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in Part B of the study who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo).'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: 20 mg LY3009104', 'description': 'A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.'}, {'id': 'OG001', 'title': 'Part A: 30 mg LY3009104', 'description': 'A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.'}, {'id': 'OG002', 'title': 'Part A: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.'}, {'id': 'OG003', 'title': 'Part B: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '578', 'spread': '28', 'groupId': 'OG000'}, {'value': '734', 'spread': '14', 'groupId': 'OG001'}, {'value': '1270', 'spread': '13', 'groupId': 'OG002'}, {'value': '741', 'spread': '33', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug', 'unitOfMeasure': 'nanomoles per liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of LY3009104.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: 20 mg LY3009104', 'description': 'A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.'}, {'id': 'OG001', 'title': 'Part A: 30 mg LY3009104', 'description': 'A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.'}, {'id': 'OG002', 'title': 'Part A: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.'}, {'id': 'OG003', 'title': 'Part B: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3960', 'spread': '27', 'groupId': 'OG000'}, {'value': '5480', 'spread': '19', 'groupId': 'OG001'}, {'value': '8490', 'spread': '14', 'groupId': 'OG002'}, {'value': '6440', 'spread': '26', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug', 'unitOfMeasure': 'hours*nanomoles per liter (h*nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of LY3009104 and had a predose and at least 1 postdose blood draw for AUC assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'Placebo tablets \\[matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104\\] administered orally once in any period during Part A of the study.'}, {'id': 'OG001', 'title': 'Part A: 20 mg LY3009104', 'description': 'A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.'}, {'id': 'OG002', 'title': 'Part A: 30 mg LY3009104', 'description': 'A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.'}, {'id': 'OG003', 'title': 'Part A: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.'}, {'id': 'OG004', 'title': 'Part B: Placebo', 'description': 'Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.'}, {'id': 'OG005', 'title': 'Part B: 40 mg LY3009104', 'description': 'A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.'}, {'id': 'OG006', 'title': 'Part B: Moxifloxacin', 'description': 'A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.'}], 'classes': [{'title': 'Drug-Related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Drug-Related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through study completion and 30-day follow-up', 'description': 'The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo) during the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104', 'description': 'First Intervention: Placebo tablets \\[matching 20-mg LY3009104\\] administered orally once.\n\nSecond Intervention: 30-mg LY3009104 dose administered orally once.\n\nThird Intervention: 40-mg LY3009104 dose administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG001', 'title': 'Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo', 'description': 'First Intervention: 20-mg LY3009104 dose administered orally once.\n\nSecond Intervention: 30-mg LY3009104 dose administered orally once.\n\nThird Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG002', 'title': 'Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104', 'description': 'First Intervention: 20-mg LY3009104 dose administered orally once.\n\nSecond Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.\n\nThird Intervention: 40-mg LY3009104 dose administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG003', 'title': 'Part B: 40 mg LY3009104, Placebo, Moxifloxacin', 'description': 'First Intervention: 40-mg LY3009104 dose administered orally once.\n\nSecond Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.\n\nThird Intervention: A single 400-mg moxifloxacin tablet administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG004', 'title': 'Part B: Placebo, Moxifloxacin, 40 mg LY3009104', 'description': 'First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.\n\nSecond Intervention: A single 400-mg moxifloxacin tablet administered orally once.\n\nThird Intervention: 40-mg LY3009104 dose administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG005', 'title': 'Part B: Moxifloxacin, 40 mg LY3009104, Placebo', 'description': 'First Intervention: A single 400-mg moxifloxacin tablet administered orally once.\n\nSecond Intervention: 40-mg LY3009104 dose administered orally once.\n\nThird Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG006', 'title': 'Part B: Moxifloxacin, Placebo, 40 mg LY3009104', 'description': 'First Intervention: A single 400-mg moxifloxacin tablet administered orally once.\n\nSecond Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.\n\nThird Intervention: 40-mg LY3009104 dose administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG007', 'title': 'Part B: 40 mg LY3009104, Moxifloxacin, Placebo', 'description': 'First Intervention: 40-mg LY3009104 dose administered orally once.\n\nSecond Intervention: A single 400-mg moxifloxacin tablet administered orally once.\n\nThird Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}, {'id': 'FG008', 'title': 'Part B: Placebo, 40 mg LY3009104, Moxifloxacin', 'description': 'First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.\n\nSecond Intervention: 40-mg LY3009104 dose administered orally once.\n\nThird Intervention: A single 400-mg moxifloxacin tablet administered orally once.\n\nThere was a washout of at least 3 days between each intervention.'}], 'periods': [{'title': 'First Intervention and Washout Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'comment': 'Across all reporting groups, study drug is LY3009104, moxifloxacin, or placebo.', 'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention and Washout Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study had 2 parts. Part A: single-dose, dose-escalating study of LY3009104 \\[up to 40 milligrams (mg)\\] or placebo administered in each period. Part B: assessed the electrophysiological effects of a single supratherapeutic LY3009104 dose compared to a positive control (moxifloxacin) and placebo. Participants enrolled in either Part A or Part B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A (LY3009104 or Placebo)', 'description': 'Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose.'}, {'id': 'BG001', 'title': 'Part B (LY3009104, Moxifloxacin, or Placebo)', 'description': 'Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '39.9', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '40.8', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'More than 1 race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who received at least 1 dose of LY3009104, moxifloxacin, or placebo and had at least 1 postdose safety assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-10', 'studyFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval', 'timeFrame': 'Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose', 'description': 'The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR\\^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta\\*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period \\[-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h\\]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104', 'timeFrame': 'Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104', 'timeFrame': 'Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug'}, {'measure': 'Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)', 'timeFrame': 'Baseline through study completion and 30-day follow-up', 'description': 'The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females.\n\nPart A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected.\n\nPart B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy males or females as determined by medical history and physical examination. Are drug free, disease free, and no cardiac abnormalities.\n* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.\n* Have a clinically normal screening ECG with a measurable QT interval as judged by the investigator, and which in Part B allows accurate measurements of QT interval.\n\nExclusion Criteria:\n\n* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.\n* Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the corrected QT (QTc) analysis or have QTc greater than 450 milliseconds (msec).\n* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.'}, 'identificationModule': {'nctId': 'NCT01536951', 'briefTitle': 'A Study of LY3009104 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Placebo-Controlled, Single Dose, Dose Escalation (Part A) and a Placebo- and Positive-Controlled Study of the Effect on the Electrocardiographic QT Interval of a Single Dose (Part B) of LY3009104 in Healthy Subjects', 'orgStudyIdInfo': {'id': '14448'}, 'secondaryIdInfos': [{'id': 'I4V-MC-JADO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching LY3009104 tablets in size and appearance will be administered orally in 1 out of 3 study periods in Part A and Part B.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3009104', 'description': 'Part A. Single escalating dose of up to 40 milligrams (mg) of LY3009104 administered orally in 2 out of 3 study periods separated by at least a 3 day wash-out period between each dose.\n\nPart B. Single dose of LY3009104 determined in Part A administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.', 'interventionNames': ['Drug: LY3009104']}, {'type': 'ACTIVE_COMPARATOR', 'label': '400 mg moxifloxacin', 'description': 'Part B. 400 mg moxifloxacin will be administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.', 'interventionNames': ['Drug: moxifloxacin']}], 'interventions': [{'name': 'LY3009104', 'type': 'DRUG', 'otherNames': ['Baricitinib'], 'description': 'administered orally', 'armGroupLabels': ['LY3009104']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}, {'name': 'moxifloxacin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['400 mg moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', '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': 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'}, 'collaborators': [{'name': 'Incyte Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}