Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04586920
Status:
TERMINATED
Last Update Posted:
2025-01-03
First Post:
2020-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Terminated \\[Terminated due to safety findings\\].'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Up To Day 26', 'description': 'All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A - Placebo (Fasted)', 'description': 'Participants received single oral dose of placebo under fasting condition.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A - Placebo (Fed)', 'description': 'Participants received single oral dose of placebo under fed condition.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A - 10 Milligram (mg) LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 under fasting condition.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A - 30 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 30 mg LY3509754 under fasting condition.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A - 100 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 100 mg LY3509754 under fasting condition.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part A - 300 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fasting condition.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part A - 300 mg LY3509754 (Fed)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fed condition.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part A - 1000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part A - 2000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part B - Placebo Alone (Day 1)', 'description': 'Participants received a single oral dose of placebo on Day 1.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part B - Placebo + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Part B - 200 mg Itraconazole (Days 4 to 13)', 'description': 'Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Part B - 10 mg LY3509754 Alone (Day 1)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 on Day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'Part C - Placebo QD [Cohorts 1 and 3]', 'description': 'Participants received oral doses of placebo QD for 14 Days.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Part C - 100 mg LY3509754 QD [Cohort 1]', 'description': 'Participants received oral doses of 100 mg LY3509754 QD for 14 Days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]', 'description': 'Participants received 1.2 mg midazolam as an oral solution on Day -2.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'Part C - Placebo QD (Days 1 to 14) [Cohort 2]', 'description': 'Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG018', 'title': 'Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]', 'description': 'Participants received oral doses of 300 mg LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG019', 'title': 'Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]', 'description': 'Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG020', 'title': 'Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]', 'description': 'Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG021', 'title': 'Part C - 1000 mg LY3509754 QD [Cohort 3]', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG022', 'title': 'Part D (Japanese) - Placebo QD', 'description': 'Participants received oral doses of placebo QD for 15 Days.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG023', 'title': 'Part D (Japanese) - 400 mg LY3509754 QD', 'description': 'Participants received oral doses of 400 mg LY3509754 QD for 15 Days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG024', 'title': 'Part D (Japanese) - 1000 mg LY3509754 QD', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 15 Days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG020', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '10', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '8', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}, {'value': '8', 'groupId': 'OG020'}, {'value': '6', 'groupId': 'OG021'}, {'value': '4', 'groupId': 'OG022'}, {'value': '6', 'groupId': 'OG023'}, {'value': '6', 'groupId': 'OG024'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A - Placebo (Fasted)', 'description': 'Participants received single oral dose of placebo under fasting condition.'}, {'id': 'OG001', 'title': 'Part A - Placebo (Fed)', 'description': 'Participants received single oral dose of placebo under fed condition.'}, {'id': 'OG002', 'title': 'Part A - 10 Milligram (mg) LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 under fasting condition.'}, {'id': 'OG003', 'title': 'Part A - 30 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 30 mg LY3509754 under fasting condition.'}, {'id': 'OG004', 'title': 'Part A - 100 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 100 mg LY3509754 under fasting condition.'}, {'id': 'OG005', 'title': 'Part A - 300 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fasting condition.'}, {'id': 'OG006', 'title': 'Part A - 300 mg LY3509754 (Fed)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fed condition.'}, {'id': 'OG007', 'title': 'Part A - 1000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.'}, {'id': 'OG008', 'title': 'Part A - 2000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.'}, {'id': 'OG009', 'title': 'Part B - Placebo Alone (Day 1)', 'description': 'Participants received a single oral dose of placebo on Day 1.'}, {'id': 'OG010', 'title': 'Part B - Placebo + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.'}, {'id': 'OG011', 'title': 'Part B - 200 mg Itraconazole (Days 4 to 13)', 'description': 'Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.'}, {'id': 'OG012', 'title': 'Part B - 10 mg LY3509754 Alone (Day 1)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 on Day 1.'}, {'id': 'OG013', 'title': 'Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.'}, {'id': 'OG014', 'title': 'Part C - Placebo QD [Cohorts 1 and 3]', 'description': 'Participants received oral doses of placebo QD for 14 Days.'}, {'id': 'OG015', 'title': 'Part C - 100 mg LY3509754 QD [Cohort 1]', 'description': 'Participants received oral doses of 100 mg LY3509754 QD for 14 Days.'}, {'id': 'OG016', 'title': 'Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]', 'description': 'Participants received 1.2 mg midazolam as an oral solution on Day -2.'}, {'id': 'OG017', 'title': 'Part C - Placebo QD (Days 1 to 14) [Cohort 2]', 'description': 'Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.'}, {'id': 'OG018', 'title': 'Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]', 'description': 'Participants received oral doses 300 mg of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.'}, {'id': 'OG019', 'title': 'Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]', 'description': 'Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.'}, {'id': 'OG020', 'title': 'Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]', 'description': 'Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.'}, {'id': 'OG021', 'title': 'Part C - 1000 mg LY3509754 QD [Cohort 3]', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}, {'id': 'OG022', 'title': 'Part D (Japanese) - Placebo QD', 'description': 'Participants received oral doses of placebo QD for 14 Days.'}, {'id': 'OG023', 'title': 'Part D (Japanese) - 400 mg LY3509754 QD', 'description': 'Participants received oral doses of 400 mg LY3509754 QD for 14 Days.'}, {'id': 'OG024', 'title': 'Part D (Japanese) - 1000 mg LY3509754 QD', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}], 'classes': [{'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'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 26', 'description': 'An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above.\n\nThe number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A - 10 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 under fasting condition.'}, {'id': 'OG001', 'title': 'Part A - 30 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 30 mg LY3509754 under fasting condition.'}, {'id': 'OG002', 'title': 'Part A - 100 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 100 mg LY3509754 under fasting condition.'}, {'id': 'OG003', 'title': 'Part A - 300 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fasting condition.'}, {'id': 'OG004', 'title': 'Part A - 300 mg LY3509754 (Fed)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fed condition.'}, {'id': 'OG005', 'title': 'Part A - 1000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.'}, {'id': 'OG006', 'title': 'Part A - 2000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.'}, {'id': 'OG007', 'title': 'Part B - 10 mg LY3509754 Alone (Day 1)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 on Day 1.'}, {'id': 'OG008', 'title': 'Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'spread': '28', 'groupId': 'OG000'}, {'value': '49.0', 'spread': '26', 'groupId': 'OG001'}, {'value': '136', 'spread': '73', 'groupId': 'OG002'}, {'value': '384', 'spread': '62', 'groupId': 'OG003'}, {'value': '278', 'spread': '72', 'groupId': 'OG004'}, {'value': '1390', 'spread': '55', 'groupId': 'OG005'}, {'value': '2310', 'spread': '13', 'groupId': 'OG006'}, {'value': '15.7', 'spread': '24', 'groupId': 'OG007'}, {'value': '43.3', 'spread': '41', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose.', 'description': 'PK: Cmax of LY3509754 in Parts A and B.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LY3509754 or itraconazole and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'PK: Cmax of LY3509754 in Parts C and D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C - 100 mg LY3509754 QD [Cohort 1]', 'description': 'Participants received oral doses of 100 mg LY3509754 QD for 14 Days.'}, {'id': 'OG001', 'title': 'Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]', 'description': 'Participants received oral doses of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.'}, {'id': 'OG002', 'title': 'Part C - 1000 mg LY3509754 QD [Cohort 3]', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}, {'id': 'OG003', 'title': 'Part D (Japanese) - 400 mg LY3509754 QD', 'description': 'Participants received oral doses of 400 mg LY3509754 QD for 14 Days.'}, {'id': 'OG004', 'title': 'Part D(Japanese) - 1000 mg LY3509754 QD', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}], 'classes': [{'categories': [{'measurements': [{'value': '218', 'spread': '52', 'groupId': 'OG000'}, {'value': '458', 'spread': '50', 'groupId': 'OG001'}, {'value': '1160', 'spread': '55', 'groupId': 'OG002'}, {'value': '805', 'spread': '30', 'groupId': 'OG003'}, {'value': '2050', 'spread': '31', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose.', 'description': 'PK: Cmax of LY3509754 in Parts C and D.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LY3509754 or midazolam and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A - 10 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 under fasting condition.'}, {'id': 'OG001', 'title': 'Part A - 30 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 30 mg LY3509754 under fasting condition.'}, {'id': 'OG002', 'title': 'Part A - 100 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 100 mg LY3509754 under fasting condition.'}, {'id': 'OG003', 'title': 'Part A - 300 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fasting condition.'}, {'id': 'OG004', 'title': 'Part A - 300 mg LY3509754 (Fed)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fed condition.'}, {'id': 'OG005', 'title': 'Part A - 1000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.'}, {'id': 'OG006', 'title': 'Part A - 2000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.'}, {'id': 'OG007', 'title': 'Part B - 10 mg LY3509754 Alone (Day 1)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 on Day 1.'}, {'id': 'OG008', 'title': 'Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '153', 'spread': '20', 'groupId': 'OG000'}, {'value': '375', 'spread': '25', 'groupId': 'OG001'}, {'value': '1340', 'spread': '60', 'groupId': 'OG002'}, {'value': '3930', 'spread': '45', 'groupId': 'OG003'}, {'value': '2930', 'spread': '69', 'groupId': 'OG004'}, {'value': '14900', 'spread': '42', 'groupId': 'OG005'}, {'value': '26300', 'spread': '29', 'groupId': 'OG006'}, {'value': '135', 'spread': '29', 'groupId': 'OG007'}, {'value': '596', 'spread': '33', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose.', 'description': 'PK: AUC(0-24) of LY3509754 in Parts A and B.', 'unitOfMeasure': 'nanogram *hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LY3509754 or itraconazole and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'PK: AUC(0-24) of LY3509754 in Parts C and D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C - 100 mg LY3509754 QD [Cohort 1]', 'description': 'Participants received oral doses of 100 mg LY3509754 QD for 14 Days.'}, {'id': 'OG001', 'title': 'Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]', 'description': 'Participants received oral doses of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.'}, {'id': 'OG002', 'title': 'Part C - 1000 mg LY3509754 QD [Cohort 3]', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}, {'id': 'OG003', 'title': 'Part D (Japanese) - 400 mg LY3509754 QD', 'description': 'Participants received oral doses of 400 mg LY3509754 QD for 14 Days.'}, {'id': 'OG004', 'title': 'Part D (Japanese) - 1000 mg LY3509754 QD', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2170', 'spread': '41', 'groupId': 'OG000'}, {'value': '4050', 'spread': '38', 'groupId': 'OG001'}, {'value': '12200', 'spread': '42', 'groupId': 'OG002'}, {'value': '7560', 'spread': '30', 'groupId': 'OG003'}, {'value': '18000', 'spread': '22', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose.', 'description': 'PK: AUC(0-24) of LY3509754 in Parts C and D.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LY3509754 or midazolam and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A - Placebo (Fasted)', 'description': 'Participants received single oral dose of placebo under fasting condition.'}, {'id': 'FG001', 'title': 'Part A - Placebo (Fed)', 'description': 'Participants received single oral dose of placebo under fed condition.'}, {'id': 'FG002', 'title': 'Part A - 10 Milligram (mg) LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 under fasting condition.'}, {'id': 'FG003', 'title': 'Part A - 30 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 30 mg LY3509754 under fasting condition.'}, {'id': 'FG004', 'title': 'Part A - 100 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 100 mg LY3509754 under fasting condition.'}, {'id': 'FG005', 'title': 'Part A - 300 mg LY3509754 (Fasted and Fed)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fasting condition. There was a washout period of at least 5 days. Participants received a single oral dose of 300 mg LY3509754 under fed condition.'}, {'id': 'FG006', 'title': 'Part A - 1000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.'}, {'id': 'FG007', 'title': 'Part A - 2000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.'}, {'id': 'FG008', 'title': 'Part B - Placebo + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of placebo on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days twice daily (BID) on Day 4 and once daily (QD) from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.'}, {'id': 'FG009', 'title': 'Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.'}, {'id': 'FG010', 'title': 'Part C - QD [Cohorts 1 and 3]', 'description': 'Participants received oral doses of placebo QD for 14 Days.'}, {'id': 'FG011', 'title': 'Part C - 100 mg LY3509754 QD [Cohort 1]', 'description': 'Participants received oral doses of 100 mg LY3509754 QD for 14 Days.'}, {'id': 'FG012', 'title': 'Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2]', 'description': 'Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of placebo QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.'}, {'id': 'FG013', 'title': 'Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2]', 'description': 'Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of 300 mg LY3509754 QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.'}, {'id': 'FG014', 'title': 'Part C - 1000 mg LY3509754 QD [Cohort 3]', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}, {'id': 'FG015', 'title': 'Part D (Japanese) - Placebo QD', 'description': 'Participants received oral doses of placebo QD for 14 Days.'}, {'id': 'FG016', 'title': 'Part D (Japanese) - 400 mg LY3509754 QD', 'description': 'Participants received oral doses of 400 mg LY3509754 QD for 14 Days.'}, {'id': 'FG017', 'title': 'Part D (Japanese) - 1000 mg LY3509754 QD', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '8'}, {'groupId': 'FG014', 'numSubjects': '6'}, {'groupId': 'FG015', 'numSubjects': '4'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '6'}]}, {'type': 'Received At Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '8'}, {'groupId': 'FG014', 'numSubjects': '6'}, {'groupId': 'FG015', 'numSubjects': '4'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '7'}, {'groupId': 'FG014', 'numSubjects': '6'}, {'groupId': 'FG015', 'numSubjects': '4'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '6'}]}, {'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': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', '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': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', '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'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '104', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A - Placebo (Fasted)', 'description': 'Participants received single oral dose of placebo under fasting condition.'}, {'id': 'BG001', 'title': 'Part A - Placebo (Fed)', 'description': 'Participants received single oral dose of placebo under fed condition.'}, {'id': 'BG002', 'title': 'Part A - 10 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 under fasting condition.'}, {'id': 'BG003', 'title': 'Part A - 30 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 30 mg LY3509754 under fasting condition.'}, {'id': 'BG004', 'title': 'Part A - 100 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 100 mg LY3509754 under fasting condition.'}, {'id': 'BG005', 'title': 'Part A - 300 mg LY3509754 (Fasted and Fed)', 'description': 'Participants received a single oral dose of 300 mg LY3509754 under fasting condition. There was a washout period of at least 5 days. Participants received a single oral dose of 300 mg LY3509754 under fed condition.'}, {'id': 'BG006', 'title': 'Part A - 1000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.'}, {'id': 'BG007', 'title': 'Part A - 2000 mg LY3509754 (Fasted)', 'description': 'Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.'}, {'id': 'BG008', 'title': 'Part B - Placebo + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of placebo on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.'}, {'id': 'BG009', 'title': 'Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)', 'description': 'Participants received a single oral dose of 10 mg LY3509754 on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.'}, {'id': 'BG010', 'title': 'Part C - Placebo QD [Cohorts 1 and 3]', 'description': 'Participants received oral doses of placebo QD for 14 Days.'}, {'id': 'BG011', 'title': 'Part C - 100 mg LY3509754 QD [Cohort 1]', 'description': 'Participants received oral doses of 100 mg LY3509754 QD for 14 Days.'}, {'id': 'BG012', 'title': 'Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2]', 'description': 'Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of placebo QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.'}, {'id': 'BG013', 'title': 'Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2]', 'description': 'Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of 300 mg LY3509754 QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.'}, {'id': 'BG014', 'title': 'Part C - 1000 mg LY3509754 QD [Cohort 3]', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}, {'id': 'BG015', 'title': 'Part D (Japanese) - Placebo QD', 'description': 'Participants received oral doses of placebo QD for 14 Days.'}, {'id': 'BG016', 'title': 'Part D (Japanese) - 400 mg LY3509754 QD', 'description': 'Participants received oral doses of 400 mg LY3509754 QD for 14 Days.'}, {'id': 'BG017', 'title': 'Part D (Japanese) - 1000 mg LY3509754 QD', 'description': 'Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '43.5', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '16.1', 'groupId': 'BG002'}, {'value': '43.8', 'spread': '11.0', 'groupId': 'BG003'}, {'value': '52.0', 'spread': '10.4', 'groupId': 'BG004'}, {'value': '52.9', 'spread': '13.3', 'groupId': 'BG005'}, {'value': '56.8', 'spread': '4.6', 'groupId': 'BG006'}, {'value': '42.0', 'spread': '14.3', 'groupId': 'BG007'}, {'value': '33.3', 'spread': '6.8', 'groupId': 'BG008'}, {'value': '42.6', 'spread': '9.4', 'groupId': 'BG009'}, {'value': '44.0', 'spread': '8.5', 'groupId': 'BG010'}, {'value': '43.2', 'spread': '15.3', 'groupId': 'BG011'}, {'value': '38.0', 'spread': '2.8', 'groupId': 'BG012'}, {'value': '46.5', 'spread': '16.1', 'groupId': 'BG013'}, {'value': '48.2', 'spread': '12.2', 'groupId': 'BG014'}, {'value': '52.5', 'spread': '11.9', 'groupId': 'BG015'}, {'value': '54.0', 'spread': '7.5', 'groupId': 'BG016'}, {'value': '50.0', 'spread': '9.1', 'groupId': 'BG017'}, {'value': '47.45', 'spread': '12.13', 'groupId': 'BG018'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '27', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '4', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '77', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 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{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '18', 'groupId': 'BG018'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 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'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '38', 'groupId': 'BG018'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '44', 'groupId': 'BG018'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '2', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '104', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 21788989, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-11T03:44', 'hasProtocol': True}, {'date': '2021-09-21', 'size': 3905974, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-11T03:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'whyStopped': 'Terminated due to safety findings', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2020-10-13', 'resultsFirstSubmitDate': '2024-08-02', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-14', 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline up to Day 26', 'description': 'An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above.\n\nThe number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B', 'timeFrame': 'Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose.', 'description': 'PK: Cmax of LY3509754 in Parts A and B.'}, {'measure': 'PK: Cmax of LY3509754 in Parts C and D', 'timeFrame': 'Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose.', 'description': 'PK: Cmax of LY3509754 in Parts C and D.'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B', 'timeFrame': 'Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose.', 'description': 'PK: AUC(0-24) of LY3509754 in Parts A and B.'}, {'measure': 'PK: AUC(0-24) of LY3509754 in Parts C and D', 'timeFrame': 'Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose.', 'description': 'PK: AUC(0-24) of LY3509754 in Parts C and D.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38294091', 'type': 'DERIVED', 'citation': 'Datta-Mannan A, Regev A, Coutant DE, Dropsey AJ, Foster J, Jones S, Poorbaugh J, Schmitz C, Wang E, Woodman ME. Safety, Tolerability, and Pharmacokinetics of an Oral Small Molecule Inhibitor of IL-17A (LY3509754): A Phase I Randomized Placebo-Controlled Study. Clin Pharmacol Ther. 2024 May;115(5):1152-1161. doi: 10.1002/cpt.3185. Epub 2024 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overtly healthy males or females, as determined by medical history and physical examination.\n* Body mass index (BMI) within the range of 18 to 35 kilograms per meter squared (kg/m²) in Parts A, B, and C. In Part D (Japanese participants), body weight between 50 and 85 kg and BMI within the range of 18 to 28 kg/m².\n\nExclusion Criteria:\n\n* Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.\n* Women of childbearing potential are excluded from the trial.'}, 'identificationModule': {'nctId': 'NCT04586920', 'briefTitle': 'A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Randomized, Participant-and Investigator-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose, Drug-Drug Interaction and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3509754 in Healthy Non-Japanese and Japanese Participants', 'orgStudyIdInfo': {'id': '17797'}, 'secondaryIdInfos': [{'id': 'J3D-MC-FNAA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2020-003957-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3509754 - Part A', 'description': 'Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally.', 'interventionNames': ['Drug: LY3509754']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Part A', 'description': 'Placebo was administered orally.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3509754 plus Itraconazole - Part B', 'description': '10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.', 'interventionNames': ['Drug: LY3509754', 'Drug: Itraconazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus Itraconazole - Part B', 'description': 'Placebo and 200 mg Itraconazole were administered orally.', 'interventionNames': ['Drug: Placebo', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'LY3509754 plus Midazolam - Part C', 'description': 'Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.', 'interventionNames': ['Drug: LY3509754', 'Drug: Midazolam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus Midazolam - Part C', 'description': 'Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.', 'interventionNames': ['Drug: Placebo', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'LY3509754 (Japanese) - Part D', 'description': 'Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants.', 'interventionNames': ['Drug: LY3509754']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Japanese) - Part D', 'description': 'Placebo was administered orally to Japanese participants.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3509754', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3509754 (Japanese) - Part D', 'LY3509754 - Part A', 'LY3509754 plus Itraconazole - Part B', 'LY3509754 plus Midazolam - Part C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo (Japanese) - Part D', 'Placebo - Part A', 'Placebo plus Itraconazole - Part B', 'Placebo plus Midazolam - Part C']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3509754 plus Itraconazole - Part B', 'Placebo plus Itraconazole - Part B']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3509754 plus Midazolam - Part C', 'Placebo plus Midazolam - Part C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}