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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06049108
• Other study ID #: 18337
• Secondary ID: J3P-MC-FTAE
• Status: Completed
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: November 3, 2023

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 3, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-LY3871801
Administered orally

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time From zero to Infinity (AUC [0-8]) of [¹4C]-LY3871801	PK: AUC [0-8] of [¹4C]-LY3871801	Predose up to Day 7 post dose
Secondary	PK: AUC [0-8] of Total Radioactivity in Plasma and Whole Blood	PK: AUC [0-8] of Total Radioactivity in Plasma and Whole Blood	Predose up to Day 7 post dose
Secondary	PK: Maximum Concentration (Cmax) of [¹4C]-LY3871801	PK: Cmax of [¹4C]-LY3871801	Predose up to Day 7 post dose
Secondary	PK: Cmax of Total Radioactivity	PK: Cmax of Total Radioactivity	Predose up to Day 7 post dose
Secondary	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
Secondary	Total Number of Metabolites of LY3871801	Total Number of Metabolites of LY3871801	Predose up to Day 7 post dose