NCT05960851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

August 9, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

July 18, 2023

Last Update Submit

January 9, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (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

    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 Outcomes (2)

  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801

    Predose on Day 1 up to postdose on Day 17

  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801

    Predose on Day 1 up to postdose on Day 17

Study Arms (4)

LY3871801 (Part A)

EXPERIMENTAL

LY3871801 administered orally in Japanese and Non-Asian Participants.

Drug: LY3871801

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered orally in Japanese and Non-Asian Participants.

Drug: Placebo

LY3871801 (Part B)

EXPERIMENTAL

LY3871801 administered orally in Chinese Participants.

Drug: LY3871801

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered orally in Chinese Participants.

Drug: Placebo

Interventions

LY3871801DRUG

Administered orally.

LY3871801 (Part A)LY3871801 (Part B)
PlaceboDRUG

Administered orally.

Placebo (Part A)Placebo (Part B)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 27, 2023

Study Start

August 9, 2023

Primary Completion

October 25, 2023

Study Completion

October 25, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)