A Study of Carbon-14-Labelled [14C] LY3871801 in Healthy Male Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-LY3871801

• Registration Number: NCT06049108
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Primary Completion: 2023-11-03
• Study Completion: 2023-11-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-LY3871801	[14C]-LY3871801	Single dose of \[¹⁴C\]-LY3871801 administered orally

Primary Outcome Measures

Name	Time	Method
Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 7 post dose	Urinary 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	Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States