A Drug Interaction Study of LY3871801 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602675
• Other study ID #: 18336
• Secondary ID: J3P-MC-FTAD
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: April 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3871801
Administered orally.
• Methotrexate
Administered orally.
• Warfarin
Administered orally.
• Dextromethorphan
Administered orally.
• Midazolam
Administered orally.
• Repaglinide
Administered orally.

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate	Part 1: PK: Cmax of Methotrexate	Predose up to 48 hours postdose
Primary	Part 1: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Methotrexate	Part 1: PK: AUC[0-8] of Methotrexate	Predose up to 48 hours postdose
Primary	Part 2: PK: Cmax of Midazolam	Part 2: PK: Cmax of Midazolam	Predose up to 24 hours postdose
Primary	Part 2: PK: AUC[0-8] of Midazolam	Part 2: PK: AUC[0-8] of Midazolam	Predose up to 24 hours postdose
Primary	Part 2: PK: Cmax of S-warfarin	Part 2: PK: Cmax of S-warfarin	Predose up to 96 hours postdose
Primary	Part 2: PK: AUC[0-8] of S-warfarin	Part 2: PK: AUC[0-8] of S-warfarin	Predose up to 96 hours postdose
Primary	Part 2: PK: Cmax of Dextromethorphan	Part 2: PK: Cmax of Dextromethorphan	Predose up to 72 hours postdose
Primary	Part 2: PK: AUC[0-8] of Dextromethorphan	Part 2: PK: AUC[0-8] of Dextromethorphan	Predose up to 72 hours postdose
Primary	Part 2: PK: Cmax of Repaglinide	Part 2: PK: Cmax of Repaglinide	Predose up to 24 hours postdose
Primary	Part 2: PK: AUC[0-8] of Repaglinide	Part 2: PK: AUC[0-8] of Repaglinide	Predose up to 24 hours postdose