Study of Tirzepatide in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 weeks, including screening.

Official Title
-----------------
Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: 14C Tirzepatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overtly healthy males as determined by medical history, physical examination, and other screening procedures Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening Are willing to be available for the full duration of the study Exclusion Criteria: Have known allergies to tirzepatide or related compounds Have a medical condition or medical history that makes participation in the study unsafe or which may interfere in the interpretation of the results of the study Have had exposure to significant radiation within 12 months prior to dosing (for example, multiple x-ray or computed tomography [CT] scans, barium meal, being employed in a job requiring radiation exposure monitoring) Have participated in any clinical trial involving a radiolabeled substance within the past 12 months

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 Tirzepatide<br>A single dose of [14C]-tirzepatide administered subcutaneously (SC). | Drug: 14C Tirzepatide<br>* Administered SC.<br>* Other names: LY3298176;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered. | Pre-dose and up to 63 days post-dose | 
| Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered. | Pre-dose and up to 63 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Metabolites | Total Number of Metabolites. | Pre-dose and up to 63 days post-dose | 
| Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable) | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable). | Pre-dose and up to 63 days post-dose | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of tirzepatide. | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose | 
| PK: Maximum Concentration (Cmax) of Tirzepatide | PK: Maximum Concentration (Cmax) of tirzepatide. | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity. Total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL). | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose | 
| PK: Maximum Concentration (Cmax) of Total Radioactivity | PK: Cmax of total radioactivity in plasma and whole blood. The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL). | Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose |