A Phase 1, Open-Label, Two-Part Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Male Participants
Overview
- Phase
- Phase 1
- Intervention
- [14C]-LY3473329
- Conditions
- Healthy
- Sponsor
- Eli Lilly and Company
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
[14C]-LY3473329 (Part 1)
Single dose of \[¹⁴C\]-LY3473329 administered orally
Intervention: [14C]-LY3473329
LY3473329 + [14C]-LY3473329 (Part 2)
Single dose of LY3473329 administered orally followed by a single dose of \[¹⁴C\]-LY3473329 administered intravenously (IV)
Intervention: [14C]-LY3473329
LY3473329 + [14C]-LY3473329 (Part 2)
Single dose of LY3473329 administered orally followed by a single dose of \[¹⁴C\]-LY3473329 administered intravenously (IV)
Intervention: LY3473329
Outcomes
Primary Outcomes
Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time Frame: 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
Time Frame: 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
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: F of LY3473329
Secondary Outcomes
- 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: 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: 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: 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: Maximum Concentration (Cmax) of LY3473329(Day 1 up to Day 29 post dose)
- Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity(Day 1 up to Day 29 post dose)
- Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)(Day 1 up to Day 29 post dose)
- Part 1: Total Number of Metabolites of LY3473329(Day 1 up to Day 29 post dose)
- Part 2: PK: AUC (0-∞) of LY3473329(Day 1 up to Day 9 post dose)
- Part 2: PK: AUC (0-∞) of [14C]-LY3473329(Day 1 up to Day 9 post dose)
- Part 2: PK: AUC (0-∞) of Total Radioactivity(Day 1 up to Day 9 post dose)
- Part 2: PK: Cmax of LY3473329(Day 1 up to Day 9 post dose)
- Part 2: PK: Cmax of [14C]-LY3473329(Day 1 up to Day 9 post dose)
- Part 2: PK: Cmax of Total Radioactivity(Day 1 up to Day 9 post dose)
- Part 2: Total Radioactivity Recovered in Urine and Feces(Day 1 up to Day 9 post dose)