A Study of [14C]-LY3537982 in Healthy Participants
- Registration Number
- NCT05901311
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination as assessed by the investigator.
- Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
- Female participants of non-childbearing potential and male participants who follow standard contraceptive methods.
- History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description [¹⁴C]-LY3537982 + LY3537982 (Part 2) [¹⁴C]-LY3537982 Single dose of LY3537982 administered orally followed by \[¹⁴C\]-LY3537982 administered intravenously (IV). [¹⁴C]-LY3537982 (Part 1) [¹⁴C]-LY3537982 Single dose of \[¹⁴C\]-LY3537982 administered orally. [¹⁴C]-LY3537982 + LY3537982 (Part 2) LY3537982 Single dose of LY3537982 administered orally followed by \[¹⁴C\]-LY3537982 administered intravenously (IV).
- Primary Outcome Measures
Name Time Method PK: Cumulative Fefeces Predose on day 1 up to postdose on day 21 (Part 1) PK: Cumulative Fefeces
PK: Fraction of Dose Excreted in Expired Air (Feair) Predose on day 1 up to postdose on day 21 (Part 1) PK: Feair
Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur) Predose on day 1 up to postdose on day 21 (Part 1) PK: Feur
PK: Cumulative Feur Predose on day 1 up to postdose on day 21 (Part 1) PK: Cumulative Feur
PK: Fraction of Dose Excreted in Feces (Fefeces) Predose on day 1 up to postdose on day 21 (Part 1) PK: Fefeces
PK: Absolute Bioavailability (F) of LY3537982 Predose on day 1 up to postdose on day 9 (Part 2) PK: F of LY3537982
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit Inc.
🇺🇸Madison, Wisconsin, United States