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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]-LY3871801

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-LY3871801; Single dose of [¹⁴C]-LY3871801 administered orally	Drug: [14C]-LY3871801; Administered orally

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18337; J3P-MC-FTAE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No