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

NCT06049108 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18337J3P-MC-FTAE
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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 Total Radioactivity in Plasma and Whole Blood

  Predose up to Day 7 post dose

• PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801

  Predose up to Day 7 post dose

• PK: Cmax of Total Radioactivity

  Predose up to Day 7 post dose

• Total Radioactivity Recovered in Urine, Feces, and Expired Air

  Predose up to Day 7 post dose

Study Arms (1)

[14C]-LY3871801

EXPERIMENTAL

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

Drug: [14C]-LY3871801

Interventions

[14C]-LY3871801 DRUG

Administered orally

[14C]-LY3871801

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: September 15, 2023
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)