A Drug Interaction Study of LY3871801 in Healthy Participants

NCT05602675 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18336J3P-MC-FTAD
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

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

  Part 1: PK: Cmax of Methotrexate

  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

  Predose up to 48 hours postdose

• Part 2: PK: Cmax of Midazolam

  Part 2: PK: Cmax of Midazolam

  Predose up to 24 hours postdose

• Part 2: PK: AUC[0-∞] of Midazolam

  Part 2: PK: AUC\[0-∞\] of Midazolam

  Predose up to 24 hours postdose

• Part 2: PK: Cmax of S-warfarin

  Part 2: PK: Cmax of S-warfarin

  Predose up to 96 hours postdose

• Part 2: PK: AUC[0-∞] of S-warfarin

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

  Predose up to 96 hours postdose

• Part 2: PK: Cmax of Dextromethorphan

  Part 2: PK: Cmax of Dextromethorphan

  Predose up to 72 hours postdose

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

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

  Predose up to 72 hours postdose

• Part 2: PK: Cmax of Repaglinide

  Part 2: PK: Cmax of Repaglinide

  Predose up to 24 hours postdose

• Part 2: PK: AUC[0-∞] of Repaglinide

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

  Predose up to 24 hours postdose

Study Arms (2)

LY3871801 + Methotrexate (Part 1)

EXPERIMENTAL

LY3871801 administered orally in combination with methotrexate given orally.

Drug: LY3871801; Drug: Methotrexate

LY3871801 + Repaglinide + Drug Cocktail (Part 2)

EXPERIMENTAL

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

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

Interventions

LY3871801 DRUG

Administered orally.

LY3871801 + Methotrexate (Part 1); LY3871801 + Repaglinide + Drug Cocktail (Part 2)

Methotrexate DRUG

Administered orally.

LY3871801 + Methotrexate (Part 1)

Warfarin DRUG

Administered orally.

LY3871801 + Repaglinide + Drug Cocktail (Part 2)

Dextromethorphan DRUG

Administered orally.

LY3871801 + Repaglinide + Drug Cocktail (Part 2)

Midazolam DRUG

Administered orally.

LY3871801 + Repaglinide + Drug Cocktail (Part 2)

Repaglinide DRUG

Administered orally.

LY3871801 + Repaglinide + Drug Cocktail (Part 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Dallas

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Methotrexate; Warfarin; Dextromethorphan; Midazolam; repaglinide

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: November 2, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)