A Phase I Study of LY3502970 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.

Official Title
-----------------
A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are overtly healthy as determined by medical evaluation Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study Exclusion Criteria: Participants who have known allergies to LY3502970, related compounds, or any components of the formulation Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study Participants who regularly use known drugs of abuse or show positive findings on drug screen

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

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

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

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: LY3502970 + [14C]-LY3502970<br>Single dose of LY3502970 administered orally followed by single dose of [¹⁴C]-LY3502970 administered intravenously (IV) | Drug: LY3502970<br>* Administered orally<br>Drug: [14C]-LY3502970<br>* Administered IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Absolute bioavailability of LY3502970 | PK: Absolute bioavailability of LY3502970 | Predose up to 16 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of Total Radioactivity | PK: AUC [0-∞] of Total Radioactivity | Predose up to 16 days postdose | 
| PK: AUC [0-∞] of [14C]-LY3502970 | PK: AUC [0-∞] of [14C]-LY3502970 | Predose up to 16 days postdose | 
| PK: AUC [0-∞] of LY3502970 | PK: AUC [0-∞] of LY3502970 | Predose up to 16 days postdose | 
| PK: Maximum Concentration (Cmax) of Total Radioactivity | PK: Cmax of Total Radioactivity | Predose up to 16 days postdose | 
| PK: Cmax of [14C]-LY3502970 | PK: Cmax of [14C]-LY3502970 | Predose up to 16 days postdose | 
| PK: Cmax of LY3502970 | PK: Cmax of LY3502970 | Predose up to 16 days postdose |