A Study of LY3502970 in Healthy Male 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 eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance 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 8 weeks (maximum).

Official Title
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Disposition of [¹⁴C]-LY3502970 Following Oral Administration in Healthy Male Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3502970
* Drug: [¹⁴C]-LY3502970


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males Body weight within 50 and 100 kilograms (kg), inclusive, and body mass index within the range 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive) Exclusion Criteria: Females Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product (IP); or of interfering with the interpretation of data Have a history of Gilbert's syndrome or have total bilirubin level (TBL) above upper limit of normal (ULN) at screening Have evidence of significant active neuropsychiatric disease, as determined by the investigator Have had any exposure to LY3502970 or any other glucagon-like peptide-1 (GLP-1) analogs, or other related compounds within the prior 3 months, or any history of allergies to these medications Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study Have participated, within the last 3 months, in a clinical study involving an IP. If the previous IP has a long half-life, 5 half-lives or 3 months (whichever is longer) should have passed, prior to check-in Have participated in any clinical trial involving a radiolabeled IP within 12 months prior to check-in Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies Show evidence of hepatitis C and/or positive hepatitis C antibody Show evidence of hepatitis B and/or positive hepatitis B surface antigen Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

Ages Eligible for Study
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Minimum Age: 35 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [¹⁴C]-LY3502970<br>A single dose of LY3502970 and [¹⁴C]-LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>Drug: [¹⁴C]-LY3502970<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 17 after administration of study drug | 
| Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 17 after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Pharmacokinetics (PK): Area under the Concentration-Time Curve (AUC) of LY3502970 | Plasma PK: AUC of LY3502970 | Predose up to Day 17 after administration of study drug | 
| Plasma PK: Maximum Concentration (Cmax) of LY3502970 | Plasma PK: Cmax of LY3502970 | Predose up to Day 17 after administration of study drug | 
| Plasma and Whole Blood PK of Radioactivity: AUC | Plasma and Whole Blood PK of Radioactivity: AUC | Predose up to Day 17 after administration of study drug | 
| Plasma and Whole Blood PK of Radioactivity: Cmax | Plasma and Whole Blood PK of Radioactivity: Cmax | Predose up to Day 17 after administration of study drug | 
| Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine | Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine | Predose up to Day 17 after administration of study drug |