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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3871801; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05960851

J3P-MC-FTAC (Other Identifier)

18334

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups, including a placebo group

LY3871801 (Part A)

Experimental group

Description:

LY3871801 administered orally in Japanese and Non-Asian Participants.

Treatment:

Drug: LY3871801

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered orally in Japanese and Non-Asian Participants.

Treatment:

Drug: Placebo

LY3871801 (Part B)

Experimental group

Description:

LY3871801 administered orally in Chinese Participants.

Treatment:

Drug: LY3871801

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered orally in Chinese Participants.

Treatment:

Drug: Placebo