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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Participant- and Investigator-Blind, Single-center Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LY3871801 in Healthy Asian and Non-Asian Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3871801
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3871801 (Part A)<br>LY3871801 administered orally in Japanese and Non-Asian Participants. | Drug: LY3871801<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally in Japanese and Non-Asian Participants. | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: LY3871801 (Part B)<br>LY3871801 administered orally in Chinese Participants. | Drug: LY3871801<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered orally in Chinese Participants. | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Predose up to 24 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801 | PK: Cmax of LY3871801 | Predose on Day 1 up to postdose on Day 17 | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801 | PK: AUC of LY3871801 | Predose on Day 1 up to postdose on Day 17 |