A Study of LY3337641 in Healthy Participants

Study Overview
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Brief Summary
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The purposes of this study are to determine: If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested. How a high-fat meal affects the amount of LY3337641 in the blood/body. How safe and well tolerated LY3337641 is. The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU). This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.

Official Title
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Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Reference Formulation (R)
* Drug: LY3337641 (T1)
* Drug: LY3337641 (T2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or females, as determined by medical history and physical examination Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive Have clinical laboratory test results within normal reference range for the population or investigative site Are able and willing to give signed informed consent Exclusion Criteria: Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed Have significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Ages Eligible for Study
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Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3337641 (R-fasted)<br>A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods. | Drug: Reference Formulation (R)<br>* Administered PO<br>|
| Experimental: LY3337641 (T1-fasted)<br>A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods. | Drug: LY3337641 (T1)<br>* 20 mg PO<br>|
| Experimental: LY3337641 (T1-fed)<br>A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods. | Drug: LY3337641 (T1)<br>* 20 mg PO<br>|
| Experimental: LY3337641 (T2-fasted)<br>A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods. | Drug: LY3337641 (T2)<br>* 20 mg PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3337641 | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose |