Clinical trial NCT05602675: A Drug Interaction Study of LY3871801 in Healthy Participants
Official title: Evaluation of the Effect of LY3871801 on the Pharmacokinetics of CYP450 Substrates and an OAT1/3 Substrate in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate
timeFrame: Predose up to 48 hours postdose
measure: Part 1: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Methotrexate
timeFrame: Predose up to 48 hours postdose
measure: Part 2: PK: Cmax of Midazolam
timeFrame: Predose up to 24 hours postdose
measure: Part 2: PK: AUC[0-∞] of Midazolam
timeFrame: Predose up to 24 hours postdose
measure: Part 2: PK: Cmax of S-warfarin
timeFrame: Predose up to 96 hours postdose
measure: Part 2: PK: AUC[0-∞] of S-warfarin
timeFrame: Predose up to 96 hours postdose
measure: Part 2: PK: Cmax of Dextromethorphan
timeFrame: Predose up to 72 hours postdose
measure: Part 2: PK: AUC[0-∞] of Dextromethorphan
timeFrame: Predose up to 72 hours postdose
measure: Part 2: PK: Cmax of Repaglinide
timeFrame: Predose up to 24 hours postdose
measure: Part 2: PK: AUC[0-∞] of Repaglinide
timeFrame: Predose up to 24 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: