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

NCT ID: NCT05960851

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2023-10-25

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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3871801 (Part A)

LY3871801 administered orally in Japanese and Non-Asian Participants.

Group Type EXPERIMENTAL

LY3871801

Intervention Type DRUG

Administered orally.

Placebo (Part A)

Placebo administered orally in Japanese and Non-Asian Participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

LY3871801 (Part B)

LY3871801 administered orally in Chinese Participants.

Group Type EXPERIMENTAL

LY3871801

Intervention Type DRUG

Administered orally.

Placebo (Part B)

Placebo administered orally in Chinese Participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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LY3871801

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Altasciences Clinical Los Angeles, Inc

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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J3P-MC-FTAC

Identifier Type: OTHER

Identifier Source: secondary_id

18334

Identifier Type: -

Identifier Source: org_study_id

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