A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate how much of the study drug (LY3556050), 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, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days including the screening period.

Official Title
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Disposition of [14C]-LY3556050 Following Oral Administration in Healthy Male Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]-LY3556050


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male participants who are overtly healthy as determined by medical evaluation Have a body mass index of 18.0 to 32.0 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 LY3556050, related compounds, or any components of the formulation of LY3556050, or history of significant atopy Have clinically significant abnormal BP and/or pulse rate as determined by the investigator Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-LY3556050<br>Single dose of [¹⁴C]-LY3556050 administered orally | Drug: [14C]-LY3556050<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 post dose | 
| Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma | PK: AUC(0-tlast) of LY3556050 in Plasma | Predose up to Day 21 post dose | 
| PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood | PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood | Predose up to Day 21 post dose | 
| PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of LY3556050 in Plasma | PK: AUC (0-∞) of LY3556050 in Plasma | Predose up to Day 21 post dose | 
| PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood | PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood | Predose up to Day 21 post dose | 
| PK: Maximum Concentration (Cmax) of LY3556050 in Plasma | PK: Cmax of LY3556050 in Plasma | Predose up to Day 21 post dose | 
| PK: Cmax of Total Radioactivity in Plasma and Blood | PK: Cmax of Total Radioactivity in Plasma and Blood | Predose up to Day 21 post dose | 
| Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Predose up to Day 7 post dose | 
| Total Number of Metabolites of LY3556050 | Total Number of Metabolites of LY3556050 | Predose up to Day 7 post dose |