A Drug Interaction Study of LY3154207 in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: LY3154207 Capsule

Drug: Placebo

Drug: LY3154207 Tablet

Drug: Fluconazole Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT03942029

16304

I7S-MC-HBEF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

36 participants in 8 patient groups

Cohort 1 Part A - LY3154207 Capsule

Experimental group

Description:

LY3154207 capsule (reference) administered orally, once.

Treatment:

Drug: LY3154207 Capsule

Cohort 1 Part A - LY3154207 Tablet

Experimental group

Description:

LY3154207 tablet (test) administered orally, once.

Treatment:

Drug: LY3154207 Tablet

Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole

Experimental group

Description:

LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.

Treatment:

Drug: Fluconazole Tablet

Drug: LY3154207 Tablet

Cohort 1 Part B - Placebo + Fluconazole

Experimental group

Description:

Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.

Treatment:

Drug: Fluconazole Tablet

Drug: Placebo

Cohort 2 - LY3154207 (Dose 2) + Fluconazole

Experimental group

Description:

LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.

Treatment:

Drug: Fluconazole Tablet

Drug: LY3154207 Tablet

Cohort 2 - Placebo + Fluconazole

Experimental group

Description:

Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.

Treatment:

Drug: Fluconazole Tablet

Drug: Placebo

Cohort 3 - LY3154207 + Fluconazole

Experimental group

Description:

LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.

Treatment:

Drug: Fluconazole Tablet

Drug: LY3154207 Tablet

Cohort 3 - Placebo + Fluconazole

Experimental group