A Study of Carbon-14-Labelled [14C] LY3372689 in Healthy Male Participants

Open-Label Study to Assess the Disposition of [14C]-LY3372689 Following Oral Administration in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3372689), 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 about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [¹⁴C]-LY3372689

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

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • LabCorp CRU, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male participants who are overtly healthy as determined by medical evaluation
• Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
• Males who agree to use highly effective/effective methods of contraception for 14 weeks following the dose of LY3372689 may participate in this trial.

Exclusion Criteria:

• Have a clinically significant abnormal blood pressure and/or pulse rate as determined by the investigator at screening or check-in
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Have evidence of significant active neuropsychiatric disease, as determined by the investigator
• Have participated in >3 radiolabeled drug studies in the last 12 months

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]-LY3372689; Single dose of [¹⁴C]-LY3372689 administered orally.	Drug: [¹⁴C]-LY3372689; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 17 post dose
Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 17 post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689	PK: AUC (0-∞) of Total Radioactivity and [¹⁴C]-LY3372689	Predose up to Day 17 post dose
PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689	PK: Cmax of Total Radioactivity and [¹⁴C]-LY3372689	Predose up to Day 17 post dose
PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689	PK: AUC (0-tlast) of Total Radioactivity and [¹⁴C]-LY3372689	Predose up to Day 17 post dose
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Predose up to Day 17 post dose
Total Number of Metabolites of LY3372689	Total Number of Metabolites of LY3372689	Predose up to 120 hour post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Radiolabeled Drug
• Other Study ID Numbers: 18430; I9X-MC-MTAF (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