A Study of LY3214996 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.

Official Title
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Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3214996
* Drug: [14C]-LY3214996


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly health males Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Exclusion Criteria: Females Male participants sexually active with a pregnant partner Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study Have participated in a radiolabeled drug study within the previous 4 months Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders Have a history of Gilbert's syndrome Have history or presence of psychiatric disorders Show evidence of human immunodeficiency virus (HIV) infection Show evidence of hepatitis C Show evidence of hepatitis B

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3214996 + [14C]-LY3214996<br>A single dose of LY3214996 and [14C]-LY3214996 administered orally. | Drug: LY3214996<br>* Administered orally<br>Drug: [14C]-LY3214996<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 LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Baseline through Day 8 after administration of study drug | 
| Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Baseline through Day 8 after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996 | PK: Cmax of LY3214996 | Predose through Day 8 after administration of study drug | 
| PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996 | PK: AUC(0-∞) of LY3214996 | Predose through Day 8 after administration of study drug | 
| Total Number of Metabolites of LY3214996 | Total Number of Metabolites of LY3214996 | Baseline through 48 hours after administration of study drug |