A Safety Study of LY3372689 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine the safety profile of the study drug after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3372689 or placebo and will remain in the study for up to eight weeks.

Official Title
-----------------
Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3372689

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

Intervention / Treatment
-----------------
* Drug: LY3372689
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overtly healthy vasectomized male or a female who cannot get pregnant Have a body mass index (BMI) of 18.5 to ≤30 kilograms per square meter (kg/m²) Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study Have veins suitable for ease of blood sampling Exclusion Criteria: Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3372689<br>LY3372689 administered orally | Drug: LY3372689<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo administered orally | Drug: Placebo<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through final follow-up at approximately Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372689 | PK: Cmax of LY3372689 | Day 1 postdose through Day 15 | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372689 | PK: AUC of LY3372689 | Day 1 postdose through Day 15 |