A Safety Study of LY3372689 Given By Mouth to Healthy Participants

Study Overview
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Brief Summary
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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 up to 3 doses of LY3372689 or placebo. The study will last about 12 weeks, including screening.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3372689
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy male or a female who cannot get pregnant Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening 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30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure Have or used to have health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 Have long exposure to sunlight routinely or use tanning beds regularly

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3372689<br>Escalating doses of LY3372689 administered orally in healthy participants in two of three study periods | Drug: LY3372689<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Matching placebo administered orally in healthy participants in one of three study periods | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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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 Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689 | Pharmacokinetics: Cmax of LY3372689 | Baseline through to final follow-up at approximately Week 12 | 
| Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689 | Pharmacokinetics: Tmax of LY3372689 | Baseline through final follow-up at approximately Week 12 | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689 | Pharmacokinetics: AUC of LY3372689 | Baseline through final follow-up at approximately Week 12 |