Viewing Study NCT01247350

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Ignite Creation Date: 2025-12-24 @ 5:07 PM
Ignite Modification Date: 2025-12-27 @ 3:52 PM
Study NCT ID: NCT01247350
Status: COMPLETED
Last Update Posted: 2018-04-13
First Post: 2010-11-17
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of LY3009104(Baricitinib) for Healthy Subjects
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.', 'eventGroups': [{'id': 'EG000', 'title': '2 mg LY3009104 - Single Dose', 'description': '2 mg administered orally once on Day 1', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '5 mg LY3009104 - Single Dose', 'description': '5 mg administered orally once on Day 1', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '10 mg LY3009104 - Single Dose', 'description': '10 mg administered orally on Day 1', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '14 mg LY3009104 - Single Dose', 'description': '14 mg administered orally on Day 1', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo - Single Dose', 'description': 'administered orally on Day 1', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '10 mg LY3009104 - Multiple Dose', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '14 mg LY3009104 - Multiple Dose', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Placebo - Multiple Dose', 'description': 'Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Application Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vessel Puncture Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Reticulocyte Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness Postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg LY3009104 Single Dose', 'description': '2 mg administered orally once on Day 1'}, {'id': 'OG001', 'title': '5 mg LY3009104 Single Dose', 'description': '5 mg administered orally once on Day 1'}, {'id': 'OG002', 'title': '10 mg LY3009104 Single Dose', 'description': '10 mg administered orally once on Day 1'}, {'id': 'OG003', 'title': '14 mg LY3009104 Single Dose', 'description': '14 mg administered orally once on Day 1'}, {'id': 'OG004', 'title': 'Placebo Single Dose', 'description': 'administered orally once on Day 1'}, {'id': 'OG005', 'title': '10 mg LY3009104 Multiple Dose', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days'}, {'id': 'OG006', 'title': '14 mg LY3009104 Multiple Dose', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days'}, {'id': 'OG007', 'title': 'Placebo Multiple Dose', 'description': 'Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.'}], 'classes': [{'title': 'Serious Adverse Events', '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'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Nonserious Adverse Events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses', 'description': 'Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg LY3009104 Day 1', 'description': '2 mg administered orally once on Day 1'}, {'id': 'OG001', 'title': '5 mg LY3009104 Day 1', 'description': '5 mg administered orally once on Day 1'}, {'id': 'OG002', 'title': '10 mg LY3009104 Day 1', 'description': '10 mg administered orally once on Day 1'}, {'id': 'OG003', 'title': '14 mg LY3009104 Day 1', 'description': '14 mg administered orally once on Day 1'}, {'id': 'OG004', 'title': '10 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days'}, {'id': 'OG005', 'title': '14 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'spread': '29', 'groupId': 'OG000'}, {'value': '220', 'spread': '35', 'groupId': 'OG001'}, {'value': '327', 'spread': '43', 'groupId': 'OG002'}, {'value': '410', 'spread': '19', 'groupId': 'OG003'}, {'value': '319', 'spread': '30', 'groupId': 'OG004'}, {'value': '439', 'spread': '9', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.', 'unitOfMeasure': 'nanomoles/Liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg LY3009104 Day 1', 'description': '2 mg administered orally once on Day 1'}, {'id': 'OG001', 'title': '5 mg LY3009104 Day 1', 'description': '5 mg administered orally once on Day 1'}, {'id': 'OG002', 'title': '10 mg LY3009104 Day 1', 'description': '10 mg administered orally once on Day 1'}, {'id': 'OG003', 'title': '14 mg LY3009104 Day 1', 'description': '14 mg administered orally once on Day 1'}, {'id': 'OG004', 'title': '10 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days'}, {'id': 'OG005', 'title': '14 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '403', 'spread': '10', 'groupId': 'OG000'}, {'value': '1240', 'spread': '23', 'groupId': 'OG001'}, {'value': '1730', 'spread': '21', 'groupId': 'OG002'}, {'value': '2790', 'spread': '14', 'groupId': 'OG003'}, {'value': '1970', 'spread': '18', 'groupId': 'OG004'}, {'value': '3060', 'spread': '17', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state.', 'unitOfMeasure': 'nanomoles*hour/Liter (nmol*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Half-Life(t1/2) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg LY3009104 Day 1', 'description': '2 mg administered orally once on Day 1'}, {'id': 'OG001', 'title': '5 mg LY3009104 Day 1', 'description': '5 mg administered orally once on Day 1'}, {'id': 'OG002', 'title': '10 mg LY3009104 Day 1', 'description': '10 mg administered orally once on Day 1'}, {'id': 'OG003', 'title': '14 mg LY3009104 Day 1', 'description': '14 mg administered orally once on Day 1'}, {'id': 'OG004', 'title': '10 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days'}, {'id': 'OG005', 'title': '14 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.19', 'groupId': 'OG000', 'lowerLimit': '3.88', 'upperLimit': '6.31'}, {'value': '6.82', 'groupId': 'OG001', 'lowerLimit': '5.70', 'upperLimit': '7.79'}, {'value': '6.43', 'groupId': 'OG002', 'lowerLimit': '4.37', 'upperLimit': '9.90'}, {'value': '8.48', 'groupId': 'OG003', 'lowerLimit': '6.95', 'upperLimit': '10.8'}, {'value': '8.57', 'groupId': 'OG004', 'lowerLimit': '7.43', 'upperLimit': '9.30'}, {'value': '9.41', 'groupId': 'OG005', 'lowerLimit': '7.24', 'upperLimit': '13.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Apparent Volume of Distribution of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg LY3009104 Day 1', 'description': '2 mg administered orally once on Day 1'}, {'id': 'OG001', 'title': '5 mg LY3009104 Day 1', 'description': '5 mg administered orally once on Day 1'}, {'id': 'OG002', 'title': '10 mg LY3009104 Day 1', 'description': '10 mg administered orally once on Day 1'}, {'id': 'OG003', 'title': '14 mg LY3009104 Day 1', 'description': '14 mg administered orally once on Day 1'}, {'id': 'OG004', 'title': '10 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days'}, {'id': 'OG005', 'title': '14 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '96.3', 'spread': '18', 'groupId': 'OG000'}, {'value': '99.4', 'spread': '29', 'groupId': 'OG001'}, {'value': '138', 'spread': '41', 'groupId': 'OG002'}, {'value': '150', 'spread': '19', 'groupId': 'OG003'}, {'value': '169', 'spread': '24', 'groupId': 'OG004'}, {'value': '167', 'spread': '23', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state.', 'unitOfMeasure': 'Liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Apparent Total Body Clearance of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg LY3009104 Day 1', 'description': '2 mg administered orally once on Day 1'}, {'id': 'OG001', 'title': '5 mg LY3009104 Day 1', 'description': '5 mg administered orally once on Day 1'}, {'id': 'OG002', 'title': '10 mg LY3009104 Day 1', 'description': '10 mg administered orally once on Day 1'}, {'id': 'OG003', 'title': '14 mg LY3009104 Day 1', 'description': '14 mg administered orally once on Day 1'}, {'id': 'OG004', 'title': '10 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days'}, {'id': 'OG005', 'title': '14 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '11', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '22', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '20', 'groupId': 'OG002'}, {'value': '12.2', 'spread': '17', 'groupId': 'OG003'}, {'value': '13.7', 'spread': '18', 'groupId': 'OG004'}, {'value': '12.3', 'spread': '17', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose', 'description': 'Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state.', 'unitOfMeasure': 'Liter/hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg LY3009104 Day 1', 'description': '2 mg administered orally once on Day 1'}, {'id': 'OG001', 'title': '5 mg LY3009104 Day 1', 'description': '5 mg administered orally once on Day 1'}, {'id': 'OG002', 'title': '10 mg LY3009104 Day 1', 'description': '10 mg administered orally once on Day 1'}, {'id': 'OG003', 'title': '14 mg LY3009104 Day 1', 'description': '14 mg administered orally once on Day 1'}, {'id': 'OG004', 'title': '10 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days'}, {'id': 'OG005', 'title': '14 mg LY3009104 Day 17', 'description': 'Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '1.25', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '2.10'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose', 'description': 'Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Renal Excretion of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg LY3009104 Day 1', 'description': '10 mg administered orally on Day 1'}, {'id': 'OG001', 'title': '14 mg LY3009104 Day 1', 'description': '14 mg administered orally on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '7', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: continuous for 24 hours', 'description': 'Percentage of LY3009104 excreted in urine from zero to 24 hours.', 'unitOfMeasure': 'percentage of drug', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were administered study drug (10 mg and 14 mg LY3009104 per protocol) and had pharmacokinetics (PK) samples for the analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2 mg LY3009104 (Baricitinib)', 'description': '2 mg administered orally once on Day 1 (single dose)'}, {'id': 'FG001', 'title': '5 mg LY3009104', 'description': '5 mg administered orally once on Day 1 (single dose)'}, {'id': 'FG002', 'title': '10 mg LY3009104', 'description': '10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)'}, {'id': 'FG003', 'title': '14 mg LY3009104', 'description': '14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Received Multiple Doses of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '2 mg LY3009104', 'description': '2 mg administered orally once on Day 1 (single dose)'}, {'id': 'BG001', 'title': '5 mg LY3009104', 'description': '5 mg administered orally once on Day 1 (single dose)'}, {'id': 'BG002', 'title': '10 mg LY3009104', 'description': '10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose)'}, {'id': 'BG003', 'title': '14 mg LY3009104', 'description': '14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '46.7', 'spread': '9.0', 'groupId': 'BG002'}, {'value': '51.1', 'spread': '6.3', 'groupId': 'BG003'}, {'value': '45.1', 'spread': '10.7', 'groupId': 'BG004'}, {'value': '47.4', 'spread': '10.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-06', 'studyFirstSubmitDate': '2010-11-17', 'resultsFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-06', 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinically Significant Effects', 'timeFrame': 'Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses', 'description': 'Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state.'}, {'measure': 'Pharmacokinetics: Half-Life(t1/2) of LY3009104', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.'}, {'measure': 'Pharmacokinetics: Apparent Volume of Distribution of LY3009104', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose', 'description': 'Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state.'}, {'measure': 'Pharmacokinetics: Apparent Total Body Clearance of LY3009104', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose', 'description': 'Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state.'}, {'measure': 'Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)', 'timeFrame': 'Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose', 'description': 'Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state.'}, {'measure': 'Pharmacokinetics: Renal Excretion of LY3009104', 'timeFrame': 'Day 1: continuous for 24 hours', 'description': 'Percentage of LY3009104 excreted in urine from zero to 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males or females. Male subjects: Agree to use 2 forms of highly effective methods of birth control with female partners of childbearing potential for the specified duration. Female subjects: Females must not be pregnant, breastfeeding, or at risk to become pregnant during study participation. Female subjects of childbearing potential must test negative for pregnancy at screening and agree to use 2 forms of highly effective methods of birth control, or remain abstinent for the specified duration.\n* Up to third generation Japanese, that is defined as all of the subject's biological grandparents are of exclusive Japanese decent and have been born in Japan.\n* Are between the body mass index (BMI) of 18.0 and 30.0 kg/m², inclusive at screening.\n\nExclusion Criteria:\n\n* Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.\n* Have a history of or current 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* Show evidence of significant active neuropsychiatric disease.\n* Have current or recent history of herpes zoster or simplex in the last 90 days prior to randomization, or history of herpes zoster, such as disseminated herpes zoster involving multiple dermatomes, ocular involvement, including herpes zoster involving the ophthalmic branch of the trigeminal nerve.\n* Have or have a history of rheumatoid arthritis.\n* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.\n* History of stomach or intestinal surgery, except that appendectomy and/or cholecystectomy will be allowed.\n* Receipt of blood products within 2 months prior to study entry."}, 'identificationModule': {'nctId': 'NCT01247350', 'briefTitle': 'A Study of LY3009104(Baricitinib) for Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Japanese Healthy Subjects', 'orgStudyIdInfo': {'id': '14089'}, 'secondaryIdInfos': [{'id': 'I4V-JE-JADM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 mg LY3009104 (Cohort 1)', 'description': '2mg administered once on day 1 (single dose)', 'interventionNames': ['Drug: LY3009104']}, {'type': 'EXPERIMENTAL', 'label': '5 mg LY3009104 (Cohort 2)', 'description': '5mg administered once on day 1 (single dose)', 'interventionNames': ['Drug: LY3009104']}, {'type': 'EXPERIMENTAL', 'label': '10 mg LY3009104 (Cohort 3)', 'description': '10 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)', 'interventionNames': ['Drug: LY3009104']}, {'type': 'EXPERIMENTAL', 'label': '14 mg LY3009104 (Cohort 4 )', 'description': '14 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)', 'interventionNames': ['Drug: LY3009104']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3009104', 'type': 'DRUG', 'otherNames': ['baricitinib'], 'description': 'Administered orally', 'armGroupLabels': ['10 mg LY3009104 (Cohort 3)', '14 mg LY3009104 (Cohort 4 )', '2 mg LY3009104 (Cohort 1)', '5 mg LY3009104 (Cohort 2)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, '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'}}}}