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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: [¹⁴C]-LY3372689


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [¹⁴C]-LY3372689<br>Single dose of [¹⁴C]-LY3372689 administered orally. | Drug: [¹⁴C]-LY3372689<br>* Administered orally.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiolabeled Drug