A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants
- Registration Number
- NCT06342596
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate how much of the study drug (LY3473329), 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 male 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 is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
- Male participants who are overtly healthy as determined by medical evaluation
- Have a body mass index of 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive
- Males who agree to use highly effective or effective methods of contraception
- Have known allergies to LY3473329, related compounds, or any components of the formulation, or history of significant atopy
- Have a history of constipation or have had acute constipation within 3 weeks prior to check-in
- Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in. Any previous radiolabeled study intervention must have been received more than 12 months prior to check-in
- Have used or plan to use over-the-counter or prescription medication within 14 days prior to dosing, or any medications or products known to alter drug absorption, metabolism, or elimination processes
- Have participated, within the last 3 months, in a clinical study involving an investigational product
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description [14C]-LY3473329 (Part 1) [14C]-LY3473329 Single dose of \[¹⁴C\]-LY3473329 administered orally LY3473329 + [14C]-LY3473329 (Part 2) [14C]-LY3473329 Single dose of LY3473329 administered orally followed by a single dose of \[¹⁴C\]-LY3473329 administered intravenously (IV) LY3473329 + [14C]-LY3473329 (Part 2) LY3473329 Single dose of LY3473329 administered orally followed by a single dose of \[¹⁴C\]-LY3473329 administered intravenously (IV)
- Primary Outcome Measures
Name Time Method Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered Day 1 up to Day 29 post dose Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered Day 1 up to Day 29 post dose Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329 Day 1 up to Day 9 post dose Part 2: PK: F of LY3473329
- Secondary Outcome Measures
Name Time Method Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329 Day 1 up to Day 29 post dose Part 1: PK: AUC(0-tlast) of LY3473329
Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity Day 1 up to Day 29 post dose Part 1: PK: AUC(0-tlast) of Total Radioactivity
Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329 Day 1 up to Day 29 post dose Part 1: PK: AUC(0-∞) of LY3473329
Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity Day 1 up to Day 29 post dose Part 1: PK: AUC(0-∞) of Total Radioactivity
Part 1: PK: Maximum Concentration (Cmax) of LY3473329 Day 1 up to Day 29 post dose Part 1: PK: Cmax of LY3473329
Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity Day 1 up to Day 29 post dose Part 1: PK: Cmax of Total Radioactivity
Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) Day 1 up to Day 29 post dose Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
Part 1: Total Number of Metabolites of LY3473329 Day 1 up to Day 29 post dose Part 1: Total Number of Metabolites of LY3473329
Part 2: PK: AUC (0-∞) of LY3473329 Day 1 up to Day 9 post dose Part 2: PK: AUC (0-∞) of LY3473329
Part 2: PK: AUC (0-∞) of [14C]-LY3473329 Day 1 up to Day 9 post dose Part 2: PK: AUC (0-∞) of \[14C\]-LY3473329
Part 2: PK: AUC (0-∞) of Total Radioactivity Day 1 up to Day 9 post dose Part 2: PK: AUC (0-∞) of Total Radioactivity
Part 2: PK: Cmax of LY3473329 Day 1 up to Day 9 post dose Part 2: PK: Cmax of LY3473329
Part 2: PK: Cmax of [14C]-LY3473329 Day 1 up to Day 9 post dose Part 2: PK: Cmax of \[14C\]-LY3473329
Part 2: PK: Cmax of Total Radioactivity Day 1 up to Day 9 post dose Part 2: PK: Cmax of Total Radioactivity
Part 2: Total Radioactivity Recovered in Urine and Feces Day 1 up to Day 9 post dose Part 2: Total Radioactivity Recovered in Urine and Feces
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit
🇬🇧Holbeck, Leeds, United Kingdom