A Study of LY3871801 in Healthy Asian and Non-Asian Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3871801

• Registration Number: NCT05960851
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these participants. The study will be conducted in two parts (A \& B). The study will last up to approximately 24 days excluding the screening period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Study Start: 2023-08-09
• Primary Completion: 2023-10-25
• Study Completion: 2023-10-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Are Japanese, Chinese, or Non-Asian participants who are overtly healthy as determined by medical evaluation
• Have body weight of >/= 45 kilograms (kg) & a body mass index (BMI) in the range of 18.5 to 29.5 kilogram per square meter (kg/m²). The Japanese participants must have a body weight of 45 to 85 kg and a BMI of 18.0 to 29.5 kg/m²

Exclusion Criteria

• Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy
• Have a significant history of or current cardiovascular or heart failure (based on New York Heart Association Functional Classification), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Are females who are lactating or have a positive pregnancy test at screening or Day 1
• Positive for drug or alcohol screen at screening or Day -1
• Smoke more than 10 cigarettes per day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Part B)	Placebo	Placebo administered orally in Chinese Participants.
LY3871801 (Part B)	LY3871801	LY3871801 administered orally in Chinese Participants.
Placebo (Part A)	Placebo	Placebo administered orally in Japanese and Non-Asian Participants.
LY3871801 (Part A)	LY3871801	LY3871801 administered orally in Japanese and Non-Asian Participants.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Predose up to 24 days post dose	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801	Predose on Day 1 up to postdose on Day 17	PK: Cmax of LY3871801
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801	Predose on Day 1 up to postdose on Day 17	PK: AUC of LY3871801

Trial Locations

Locations (1)

Altasciences Clinical Los Angeles, Inc; 🇺🇸 Cypress, California, United States