A Drug Interaction Study of LY3871801 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05602675
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description LY3871801 + Methotrexate (Part 1) LY3871801 LY3871801 administered orally in combination with methotrexate given orally. LY3871801 + Repaglinide + Drug Cocktail (Part 2) LY3871801 LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally. LY3871801 + Repaglinide + Drug Cocktail (Part 2) Dextromethorphan LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally. LY3871801 + Repaglinide + Drug Cocktail (Part 2) Repaglinide LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally. LY3871801 + Methotrexate (Part 1) Methotrexate LY3871801 administered orally in combination with methotrexate given orally. LY3871801 + Repaglinide + Drug Cocktail (Part 2) Warfarin LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally. LY3871801 + Repaglinide + Drug Cocktail (Part 2) Midazolam LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally.
- Primary Outcome Measures
Name Time Method Part 2: PK: AUC[0-∞] of Dextromethorphan Predose up to 72 hours postdose Part 2: PK: AUC\[0-∞\] of Dextromethorphan
Part 2: PK: AUC[0-∞] of Midazolam Predose up to 24 hours postdose Part 2: PK: AUC\[0-∞\] of Midazolam
Part 2: PK: Cmax of Repaglinide Predose up to 24 hours postdose Part 2: PK: Cmax of Repaglinide
Part 2: PK: Cmax of Dextromethorphan Predose up to 72 hours postdose Part 2: PK: Cmax of Dextromethorphan
Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate Predose up to 48 hours postdose Part 1: PK: Cmax of Methotrexate
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
Part 2: PK: Cmax of Midazolam Predose up to 24 hours postdose Part 2: PK: Cmax of Midazolam
Part 2: PK: Cmax of S-warfarin Predose up to 96 hours postdose Part 2: PK: Cmax of S-warfarin
Part 2: PK: AUC[0-∞] of S-warfarin Predose up to 96 hours postdose Part 2: PK: AUC\[0-∞\] of S-warfarin
Part 2: PK: AUC[0-∞] of Repaglinide Predose up to 24 hours postdose Part 2: PK: AUC\[0-∞\] of Repaglinide
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Covance Dallas
🇺🇸Dallas, Texas, United States