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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C]-LY3866288; Drug: LY3866288

Study type: Interventional

Funder types: Industry

Identifiers

NCT06644378

18885 (Other Identifier)

J4G-OX-JZVB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Part A: [14C]-LY3866288

Experimental group

Description:

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

Treatment:

Drug: [14C]-LY3866288

Drug: [14C]-LY3866288

Part B: LY3866288 + [14C]-LY3866288

Experimental group

Description:

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

Treatment:

Drug: [14C]-LY3866288

Drug: LY3866288

Drug: [14C]-LY3866288