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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05960851

Enrollment

Registered

2023-07-27

Start date

2023-08-09

Completion date

2023-10-25

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLY3871801

Administered orally.

DRUGPlacebo

Administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026