A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT06194500
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Male

Eligibility Criteria

Sex
MALE
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will be conducted in healthy males and has two parts. In Part A, participants will receive carbon-14 (14C) radiolabeled LY3549492 (\[14C\] LY3549492) given by mouth. In Part B, participants will receive LY3549492 by mouth. Three hours later, participants will receive \[14C\] LY3549492 given into a vein. The radioactive substance C14 will be incorporated into the study drug to investigate the study drug and breakdown products to find out how much of these passes from blood into urine, stool, and breath. The study will last about 2 months in Part A and about 1½ months in Part B. This includes screening, treatment, and follow-up visits.

Key Dates

Start date
Jan 3, 2024
Status verified
Mar 2024
Primary completion
Feb 15, 2024
Completion
Feb 15, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Carbon-14-Labeled [14C]-LY3549492 - Part A
    Carbon-14-Labeled \[14C\]-LY3549492 administered as oral solution.
  • Experimental: LY3549492 + [14C]-LY3549492 - Part B
    LY3549492 administered as oral solution followed 3 hours later by \[14C\] LY3549492 will be administered as intravenous (IV) infusion.

Primary Outcome Measure

Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A [ Time Frame: Predose up to Day 24 postdose in Part A ]