A Drug Interaction Study of LY3871801 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05602675
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.5
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3871801; Drug: Methotrexate; Drug: Warfarin; Drug: Dextromethorphan; Drug: Midazolam; Drug: Repaglinide	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Evaluation of the Effect of LY3871801 on the Pharmacokinetics of CYP450 Substrates and an OAT1/3 Substrate in Healthy Participants
• Actual Study Start Date: Nov 2, 2022
• Anticipated Primary Completion Date: Mar 19, 2023
• Anticipated Study Completion Date: Mar 19, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3871801 + Methotrexate (Part 1) LY3871801 administered orally in combination with methotrexate given orally.	Drug: LY3871801; Administered orally.; Drug: Methotrexate; Administered orally.
Experimental: 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.	Drug: LY3871801; Administered orally.; Drug: Warfarin; Administered orally.; Drug: Dextromethorphan; Administered orally.; Drug: Midazolam; Administered orally.; Drug: Repaglinide; Administered orally.

Outcome Measures

Primary Outcome Measures

1. Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate [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 [Predose up to 48 hours postdose]

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

3. Part 2: PK: Cmax of Midazolam [Predose up to 24 hours postdose]

   Part 2: PK: Cmax of Midazolam

4. Part 2: PK: AUC[0-∞] of Midazolam [Predose up to 24 hours postdose]

   Part 2: PK: AUC[0-∞] of Midazolam

5. Part 2: PK: Cmax of S-warfarin [Predose up to 96 hours postdose]

   Part 2: PK: Cmax of S-warfarin

6. Part 2: PK: AUC[0-∞] of S-warfarin [Predose up to 96 hours postdose]

   Part 2: PK: AUC[0-∞] of S-warfarin

7. Part 2: PK: Cmax of Dextromethorphan [Predose up to 72 hours postdose]

   Part 2: PK: Cmax of Dextromethorphan

8. Part 2: PK: AUC[0-∞] of Dextromethorphan [Predose up to 72 hours postdose]

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

9. Part 2: PK: Cmax of Repaglinide [Predose up to 24 hours postdose]

   Part 2: PK: Cmax of Repaglinide

10. Part 2: PK: AUC[0-∞] of Repaglinide [Predose up to 24 hours postdose]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Dallas	Dallas	Texas	United States	75247

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT05602675
• Other Study ID Numbers: 18336; J3P-MC-FTAD
• First Posted: Nov 2, 2022
• Last Update Posted: Dec 28, 2022
• Last Verified: Dec 16, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Repaglinide; Methotrexate; Midazolam; Dextromethorphan; Warfarin

Study Results

No Results Posted as of Dec 28, 2022