A Drug Interaction Study of LY3154207 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3154207 Tablet; Drug: LY3154207 Capsule; Drug: Fluconazole Tablet

• Registration Number: NCT03942029
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-06-21
• Primary Completion: 2019-12-28
• Study Completion: 2019-12-28
• Status Verified: 2020-01-15
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m²)
• Have clinical laboratory test results within acceptable range for the population

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Exclusion Criteria

• Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1 Part B - Placebo + Fluconazole	Fluconazole Tablet	Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Cohort 2 - LY3154207 (Dose 2) + Fluconazole	Fluconazole Tablet	LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
Cohort 2 - Placebo + Fluconazole	Fluconazole Tablet	Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Cohort 3 - LY3154207 + Fluconazole	Fluconazole Tablet	LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole	Fluconazole Tablet	LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
Cohort 1 Part B - Placebo + Fluconazole	Placebo	Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Cohort 2 - LY3154207 (Dose 2) + Fluconazole	LY3154207 Tablet	LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
Cohort 3 - LY3154207 + Fluconazole	LY3154207 Tablet	LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole	LY3154207 Tablet	LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
Cohort 2 - Placebo + Fluconazole	Placebo	Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Cohort 1 Part A - LY3154207 Capsule	LY3154207 Capsule	LY3154207 capsule (reference) administered orally, once.
Cohort 1 Part A - LY3154207 Tablet	LY3154207 Tablet	LY3154207 tablet (test) administered orally, once.
Cohort 3 - Placebo + Fluconazole	Placebo	Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
Cohort 3 - Placebo + Fluconazole	Fluconazole Tablet	Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	Baseline up to 11 weeks	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Blood Pressure (BP)	Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole	BP measured by ambulatory blood pressure monitoring (ABPM)
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of LY3154207	Baseline up to 48 hours postdose	PK: AUC(0-tlast) of LY3154207
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207	Baseline up to 48 hours postdose	PK: AUC(0-inf) of LY3154207
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207	Baseline up to 48 hours postdose	PK: Cmax of LY3154207
Change from Baseline in Pulse Rate (PR)	Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole	PR measured by ABPM

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States