A Drug Interaction Study of LY3871801 in Healthy Participants

Eli Lilly and Company39 enrolled

Overview

The main purpose of this study is to determine the effect of LY3871801 when administered orally on the levels of methotrexate (part 1), drug cocktail (warfarin, dextromethorphan, and midazolam) and repaglinide (part 2) in the blood stream when administered orally in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 25 days for each participant.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LY3871801DRUG

Administered orally.

MethotrexateDRUG

Administered orally.

WarfarinDRUG

Administered orally.

Dextromethorphan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination. * Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 40.0 kilograms per meter squared (kg/m²) * Male or female participants not of childbearing potential (both parts) and for part 2, female participants of child bearing potential are eligible. Exclusion Criteria: * Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy. * Have known allergies to drugs including methotrexate, folic acid, repaglinide, warfarin, dextromethorphan, and midazolam that would pose an unacceptable risk to the participant. * Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator * Have used or intend to use prescription or nonprescription medication * Have a positive (not indeterminate) QuantiFERON®-TB Gold test

Locations (1)

Covance Dallas

Dallas, Texas, United States

Outcomes

Primary Outcomes

Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate

Part 1: PK: Cmax of Methotrexate

Time frame: Predose up to 48 hours postdose

Part 1: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Methotrexate

Part 1: PK: AUC\[0-∞\] of Methotrexate

Time frame: Predose up to 48 hours postdose

Part 2: PK: Cmax of Midazolam

Time frame: Predose up to 24 hours postdose

Part 2: PK: AUC[0-∞] of Midazolam

Part 2: PK: AUC\[0-∞\] of Midazolam

Time frame: Predose up to 24 hours postdose

Part 2: PK: Cmax of S-warfarin

Time frame: Predose up to 96 hours postdose

Part 2: PK: AUC[0-∞] of S-warfarin

Part 2: PK: AUC\[0-∞\] of S-warfarin

Time frame: Predose up to 96 hours postdose

Part 2: PK: Cmax of Dextromethorphan

Time frame: Predose up to 72 hours postdose

Part 2: PK: AUC[0-∞] of Dextromethorphan

Part 2: PK: AUC\[0-∞\] of Dextromethorphan

Time frame: Predose up to 72 hours postdose

Part 2: PK: Cmax of Repaglinide

Data from ClinicalTrials.gov

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