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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05960851
• Other study ID #: 18334
• Secondary ID: J3P-MC-FTAC
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2023
• Est. completion date: October 25, 2023

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 25, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3871801
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801	PK: Cmax of LY3871801	Predose on Day 1 up to postdose on Day 17
Secondary	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