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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06049108
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 1.6
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: [14C]-LY3871801	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-LY3871801 in Healthy Male Participants
• Anticipated Study Start Date: Sep 15, 2023
• Anticipated Primary Completion Date: Nov 4, 2023
• Anticipated Study Completion Date: Nov 4, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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

3. PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801 [Predose up to Day 7 post dose]

   PK: Cmax of [¹⁴C]-LY3871801

4. PK: Cmax of Total Radioactivity [Predose up to Day 7 post dose]

   PK: Cmax of Total Radioactivity

5. 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

6. Total Number of Metabolites of LY3871801 [Predose up to Day 7 post dose]

   Total Number of Metabolites of LY3871801

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT06049108
• Other Study ID Numbers: 18337; J3P-MC-FTAE
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 15, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 21, 2023