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Completed

NCT Number: NCT05602675

A Drug Interaction Study of LY3871801 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3871801

Drug

Administered orally.

methotrexate

Drug

Administered orally.

Warfarin

Drug

Administered orally.

dextromethorphan

Drug

Administered orally.

midazolam

Drug

Administered orally.

repaglinide

Drug

Administered orally.

Primary outcomes

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

    Time frame: Predose up to 48 hours postdose

    Part 1: PK: Cmax of Methotrexate

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

    Time frame: Predose up to 48 hours postdose

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

  3. Part 2: PK: Cmax of Midazolam

    Time frame: Predose up to 24 hours postdose

    Part 2: PK: Cmax of Midazolam

  4. Part 2: PK: AUC[0-∞] of Midazolam

    Time frame: Predose up to 24 hours postdose

    Part 2: PK: AUC[0-∞] of Midazolam

  5. Part 2: PK: Cmax of S-warfarin

    Time frame: Predose up to 96 hours postdose

    Part 2: PK: Cmax of S-warfarin

  6. Part 2: PK: AUC[0-∞] of S-warfarin

    Time frame: Predose up to 96 hours postdose

    Part 2: PK: AUC[0-∞] of S-warfarin

  7. Part 2: PK: Cmax of Dextromethorphan

    Time frame: Predose up to 72 hours postdose

    Part 2: PK: Cmax of Dextromethorphan

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

    Time frame: Predose up to 72 hours postdose

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

  9. Part 2: PK: Cmax of Repaglinide

    Time frame: Predose up to 24 hours postdose

    Part 2: PK: Cmax of Repaglinide

  10. Part 2: PK: AUC[0-∞] of Repaglinide

    Time frame: Predose up to 24 hours postdose

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Evaluation of the Effect of LY3871801 on the Pharmacokinetics of CYP450 Substrates and an OAT1/3 Substrate in Healthy Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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