A Drug Interaction Study of LY3871801 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Methotrexate; Drug: Dextromethorphan; Drug: Warfarin; Drug: Midazolam; Drug: LY3871801; Drug: Repaglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05602675

J3P-MC-FTAD (Other Identifier)

18336

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

LY3871801 + Methotrexate (Part 1)

Experimental group

Description:

LY3871801 administered orally in combination with methotrexate given orally.

Treatment:

Drug: LY3871801

Drug: Methotrexate

LY3871801 + Repaglinide + Drug Cocktail (Part 2)

Experimental group

Description:

LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally.

Treatment:

Drug: LY3871801

Drug: Repaglinide

Drug: Midazolam

Drug: Dextromethorphan

Drug: Warfarin