A Drug Interaction Study of LY3154207 in Healthy Participants
NCT ID: NCT03942029
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2019-06-21
2019-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1 Part A - LY3154207 Capsule
LY3154207 capsule (reference) administered orally, once.
LY3154207 Capsule
Administered orally as capsule
Cohort 1 Part A - LY3154207 Tablet
LY3154207 tablet (test) administered orally, once.
LY3154207 Tablet
Administered orally as tablet
Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole
LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
LY3154207 Tablet
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet
Cohort 1 Part B - Placebo + Fluconazole
Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Placebo
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet
Cohort 2 - LY3154207 (Dose 2) + Fluconazole
LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
LY3154207 Tablet
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet
Cohort 2 - Placebo + Fluconazole
Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Placebo
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet
Cohort 3 - LY3154207 + Fluconazole
LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
LY3154207 Tablet
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet
Cohort 3 - Placebo + Fluconazole
Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Placebo
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet
Interventions
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LY3154207 Capsule
Administered orally as capsule
LY3154207 Tablet
Administered orally as tablet
Placebo
Administered orally as tablet
Fluconazole Tablet
Administered orally as tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have clinical laboratory test results within acceptable range for the population
Exclusion Criteria
* Intend to use over-the-counter or prescription medication (with exception of hormonal contraceptives and acetaminophen), including herbal preparations containing St. John's wort, kava, garlic, ginger, ginkgo biloba, or guarana, within 14 days prior to Check-in and during the study
* Use of any drugs or substances that are known inducers and/or inhibitors of cytochrome P450 (CYP) 3A within 14 days prior to the administration of study drug and during the study
* Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of \< 80 milliliters per minute (mL/minute), calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
18 Years
70 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Covance Clinical Research Inc
Daytona Beach, Florida, United States
Countries
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Other Identifiers
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I7S-MC-HBEF
Identifier Type: OTHER
Identifier Source: secondary_id
16304
Identifier Type: -
Identifier Source: org_study_id
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