A Safety Study of LY3526318 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.

Official Title
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A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3526318
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or females, as determined through medical history and physical examination Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²) Have clinical laboratory test results within normal reference range Exclusion Criteria: Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality Have an abnormality in the 12-lead electrocardiogram (ECG) Have a history of clinically significant multiple or severe drug allergies Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen. Have an abnormal blood pressure Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) Are unwilling to stop herbal supplements, over the counter or prescription medicines Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study. Participants with a history of drug abuse

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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3526318 (Part A)<br>LY3526318 administered orally as single ascending doses. | Drug: LY3526318<br>* Administered orally.<br>|
| Experimental: LY3526318 (Part B)<br>LY3526318 administered orally as multiple doses. | Drug: LY3526318<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318 | PK: AUC of LY3526318 | Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8 | 
| PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | PK: Cmax of LY3526318 | Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8 |