A Study of Carbon-14-Labelled [14C] LY3871801 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 (LY3871801), 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 9 weeks including the screening period.

Official Title
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A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-LY3871801 in Healthy Male Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]-LY3871801


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 18.5 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 LY3871801, related compounds, or any components of the formulation, or a history of significant atopy Have received or intend to receive any vaccination within 30 days prior to dosing until the follow-up phone call Have participated in a radiolabeled drug study, where exposures are known to the investigator or designee, within 4 months prior to check-in, or participated in a radiolabeled drug study, where exposures are not known to the investigator or designee, within 6 months prior to check-in

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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]-LY3871801<br>Single dose of [¹⁴C]-LY3871801 administered orally | Drug: [14C]-LY3871801<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 LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 7 post dose | 
| Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 7 post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time From zero to Infinity (AUC [0-∞]) of [¹⁴C]-LY3871801 | PK: AUC [0-∞] of [¹⁴C]-LY3871801 | Predose up to Day 7 post dose | 
| PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood | PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood | Predose up to Day 7 post dose | 
| PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801 | PK: Cmax of [¹⁴C]-LY3871801 | Predose up to Day 7 post dose | 
| PK: Cmax of Total Radioactivity | PK: Cmax of Total Radioactivity | Predose up to Day 7 post dose | 
| Total Radioactivity Recovered in Urine, Feces, and Expired Air | Total Radioactivity Recovered in Urine, Feces, and Expired Air | Predose up to Day 7 post dose | 
| Total Number of Metabolites of LY3871801 | Total Number of Metabolites of LY3871801 | Predose up to Day 7 post dose |