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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05960851
Collaborator
(none)
32
Enrollment
1
Location
4
Arms
2.5
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Aug 9, 2023
Anticipated Primary Completion Date :
Oct 24, 2023
Anticipated Study Completion Date :
Oct 24, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3871801 (Part A)

LY3871801 administered orally in Japanese and Non-Asian Participants.

Drug: LY3871801
Administered orally.
Placebo Comparator: Placebo (Part A)

Placebo administered orally in Japanese and Non-Asian Participants.

Drug: Placebo
Administered orally.
Experimental: LY3871801 (Part B)

LY3871801 administered orally in Chinese Participants.

Drug: LY3871801
Administered orally.
Placebo Comparator: Placebo (Part B)

Placebo administered orally in Chinese Participants.

Drug: Placebo
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801 [Predose on Day 1 up to postdose on Day 17]

    PK: Cmax of LY3871801

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Altasciences Clinical Los Angeles, Inc Cypress California United States 90630

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05960851
Other Study ID Numbers:
  • 18334
  • J3P-MC-FTAC
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 15, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 27, 2023