A Drug Interaction Study of LY3871801 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2023-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

NCT05445440

Healthy Participants

COMPLETED PHASE1

Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir

NCT05236530

Malaria

COMPLETED PHASE1

Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients

NCT02456844

Rheumatoid Arthritis

COMPLETED PHASE1

Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects

NCT04606537

Healthy Drug Drug Interaction

COMPLETED PHASE1

A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine

NCT01358968

Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY3871801 + Methotrexate (Part 1)

LY3871801 administered orally in combination with methotrexate given orally.

Group Type EXPERIMENTAL

LY3871801

Intervention Type DRUG

Administered orally.

Methotrexate

Intervention Type DRUG

Administered orally.

LY3871801 + Repaglinide + Drug Cocktail (Part 2)

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

Group Type EXPERIMENTAL

LY3871801

Intervention Type DRUG

Administered orally.

Warfarin

Intervention Type DRUG

Administered orally.

Dextromethorphan

Intervention Type DRUG

Administered orally.

Midazolam

Intervention Type DRUG

Administered orally.

Repaglinide

Intervention Type DRUG

Administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3871801

Administered orally.

Intervention Type DRUG

Methotrexate

Administered orally.

Intervention Type DRUG

Warfarin

Administered orally.

Intervention Type DRUG

Dextromethorphan

Administered orally.

Intervention Type DRUG

Midazolam

Administered orally.

Intervention Type DRUG

Repaglinide

Administered orally.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes