Study of Food on Evacetrapib (LY2484595) in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected. The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period. This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.

Official Title
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Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Evacetrapib
* Other: High-fat Meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants as determined by medical history and physical examination Have a body mass index of 18 to 32 kilograms per square meter (kg/m²) Are able to eat a high fat breakfast and abide by the food restrictions throughout the study Exclusion Criteria: Have known allergies to evacetrapib, related compounds or any components of the formulation Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evacetrapib (Fasted)<br>130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days. | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib (Fed)<br>130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days. | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;Other: High-fat Meal<br>* Administered orally, at breakfast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib |  | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose | 
| PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib |  | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose | 
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib |  | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |