NCT05492201

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3873862 when administered either in single or multiple doses in healthy participants. The study will also assess how fast LY3873862 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 58, 72, and 72 days for Part A, B, and C, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2022

Longer than P75 for phase_1 healthy

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

August 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

August 5, 2022

Last Update Submit

May 8, 2025

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

    Baseline through 72 days

Secondary Outcomes (4)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3873862

    Predose up to 96 hours postdose

  • PK: Area Under the Concentration versus Time Curve at Steady State (AUCτ) of LY3873862

    Predose up to 96 hours postdose

  • PK: Maximum Observed Concentration (Cmax) of LY3873862

    Predose up to 96 hours postdose

  • PK: Time of Maximum observed Concentration (Tmax) of LY3873862

    Predose up to 96 hours postdose

Study Arms (6)

LY3873862 (Part A)

EXPERIMENTAL

LY3873862 administered orally as single dose.

Drug: LY3873862

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

LY3873862 (Part B)

EXPERIMENTAL

LY3873862 administered orally as multiple doses.

Drug: LY3873862

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

LY3873862 (Part C)

EXPERIMENTAL

LY3873862 administered orally as multiple doses.

Drug: LY3873862

Placebo (Part C)

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

LY3873862DRUG

Administered orally.

LY3873862 (Part A)LY3873862 (Part B)LY3873862 (Part C)
PlaceboDRUG

Administered orally.

Placebo (Part A)Placebo (Part B)Placebo (Part C)

Eligibility Criteria

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

You may qualify if:

  • Participants who are overtly healthy as determined by medical evaluation
  • Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
  • Are male or female participants, including those of childbearing potential

You may not qualify if:

  • Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematologic, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
  • Are unwilling to comply with the dietary restrictions required for this study, including the avoidance by 5 days prior to study drug administration until the final ambulatory visit the ingestion of fruits, sauces, and juices containing furanocoumarins that irreversibly inhibit cytochrome P450 (CYP)3A4. The following fruits, sauces, and juices are excluded: grapefruit, Seville oranges, pomelos, cranberry, Goji berry, and apple.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

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

August 5, 2022

First Posted

August 8, 2022

Study Start

August 11, 2022

Primary Completion

April 29, 2025

Study Completion

April 29, 2025

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)