A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.

Official Title
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A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Particle Sizes

Conditions
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Healthy

Intervention / Treatment
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* Drug: Evacetrapib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy participants of non-child bearing potential Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2) Must be willing to make oneself available for the whole study and be willing to follow study procedures Exclusion Criteria: Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.

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: Evacetrapib Reference (R)<br>Single oral dose of 130 mg evacetrapib tablet given one time during one study period. | Drug: Evacetrapib<br>* administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib Test 1 (T1)<br>Single oral dose of 130 mg evacetrapib tablet given one time during one study period. | Drug: Evacetrapib<br>* administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib Test 2 (T2)<br>Single oral dose of 130 mg evacetrapib tablet given one time during one study period. | Drug: Evacetrapib<br>* administered orally<br>* Other names: LY2484595;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib |  | Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose | 
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib |  | Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose |