A Study of [14C]-LY3537982 in Healthy Participants

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Eli Lilly and Company
Study ID
NCT05901311
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in healthy participants. This study will involve a single dose of 14C radiolabeled LY3537982. This means that a radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of LY3537982. The study will be conducted in two parts. The study will last up to 71 days and 61 days for part 1 and 2, respectively.

Key Dates

Start date
Jun 5, 2023
Status verified
Nov 2024
Primary completion
Aug 10, 2023
Completion
Aug 10, 2023

Study Design

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

Arms

  • Experimental: [¹⁴C]-LY3537982 (Part 1)
    Single dose of \[¹⁴C\]-LY3537982 administered orally.
  • Experimental: [¹⁴C]-LY3537982 + LY3537982 (Part 2)
    Single dose of LY3537982 administered orally followed by \[¹⁴C\]-LY3537982 administered intravenously (IV).

Primary Outcome Measure

Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur) [ Time Frame: Predose on day 1 up to postdose on day 21 (Part 1) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Labcorp Clinical Research Unit Inc.MadisonWisconsin53704-

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