A Study of [14C]-LY3866288 in Healthy Participants

NCT ID: NCT06644378

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2025-01-03

Brief Summary

The main purpose of this study is to evaluate how much of the study drug (LY3866288), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study will also evaluate the safety and tolerability of LY3866288.The study is conducted in two parts. The study is expected to last approximately 68 days.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part A: [14C]-LY3866288

Single dose of \[¹⁴C\]-LY3866288 administered orally.

Group Type: EXPERIMENTAL

[14C]-LY3866288

Intervention Type: DRUG

Administered orally.

Part B: LY3866288 + [14C]-LY3866288

Single dose of LY3866288 administered orally followed by a single dose of \[¹⁴C\]-LY3866288 administered intravenously (IV).

Group Type: EXPERIMENTAL

LY3866288

Intervention Type: DRUG

Administered orally.

[14C]-LY3866288

Intervention Type: DRUG

Administered IV.

Interventions

[14C]-LY3866288

Administered orally.

Intervention Type: DRUG

LY3866288

Administered orally.

Intervention Type: DRUG

[14C]-LY3866288

Administered IV.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female participants who are overtly healthy determined by medical history, physical examination, 12-lead ECGs, vital signs measurements, and clinical laboratory evaluations at screening and/or check-in by the investigator
• Have Body mass index between 18.0 and 32.0 kg/m^2 (kilograms per meter squared)
• Male participants who are infertile via bilateral orchiectomy or vasectomy
• Female participants (non-childbearing potential only for Part A) who follow standard contraceptive methods

Exclusion Criteria

• Female participants who are lactating or pregnant
• Have history of alcohol and/or drug abuse within 2 years prior to screening
• Have history or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
• Have history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Fortrea Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

J4G-OX-JZVB

Identifier Type: OTHER

Identifier Source: secondary_id

18885

Identifier Type: -

Identifier Source: org_study_id