A Study of [¹⁴C]-LY3202626 in Healthy Male Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant. This study is for research purposes only and is not intended to treat any medical condition.

Official Title
-----------------
Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: [¹⁴C]-LY3202626


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG) Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening Exclusion Criteria: Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study Have a history of constipation or have had acute constipation within 3 weeks prior to admission Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in 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
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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]-LY3202626<br>Single oral dose of LY3202626 containing 100 micro curies of radioactivity | Drug: [¹⁴C]-LY3202626<br>* Administered as solution by mouth<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered. | Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met | 
| Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered | Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax) | Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax). | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met | 
| Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞]) | Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]). | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met | 
| Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) | Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]). | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met | 
| Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma | Total number of metabolites were identified in at least 10% of the total radioactivity in plasma. | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose | 
| Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity | The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity | From Dosing Until Release Criteria Is Met |