Healthy
Conditions
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.
Interventions
DRUGLY3871801
Administered orally.
DRUGMethotrexate
Administered orally.
DRUGWarfarin
Administered orally.
DRUGDextromethorphan
Administered orally.
DRUGMidazolam
Administered orally.
DRUGRepaglinide
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: AUC[0-∞] of Midazolam | Predose up to 24 hours postdose | Part 2: PK: AUC\[0-∞\] 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: Cmax of Dextromethorphan | Predose up to 72 hours postdose | Part 2: PK: Cmax of Dextromethorphan |
| Part 2: PK: AUC[0-∞] of Dextromethorphan | Predose up to 72 hours postdose | Part 2: PK: AUC\[0-∞\] of Dextromethorphan |
| Part 2: PK: Cmax of Repaglinide | Predose up to 24 hours postdose | Part 2: PK: Cmax of Repaglinide |
| Part 2: PK: AUC[0-∞] of Repaglinide | Predose up to 24 hours postdose | Part 2: PK: AUC\[0-∞\] of Repaglinide |
Countries
United States
Outcome results
None listed