A Study of 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 and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.

Official Title
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A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Tablet Solid Fractions

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Evacetrapib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male participants who agree to use a reliable method of birth control and not donate sperm during the study and for 90 days after study completion Female participants who are not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2) Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Exclusion Criteria: Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product Have known allergies to evacetrapib, related compounds or any components of the formulation, or history of significant allergic disease as determined by the investigator Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Are women who are pregnant or lactating Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during the study Have donated blood of more than 500 milliliters (mL) within the last month Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours prior to each dose and while resident at the Clinical Research Unit (CRU) Currently smoke or use tobacco or nicotine products

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 -- Solid Fraction Test<br>Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib -- Solid Fraction Reference<br>Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods | 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 Concentration (Cmax) of Evacetrapib (LY2484595) | The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test). | Predose 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 in each period | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595) | Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-∞]) is summarized for each solid fraction control (Reference and Test). | Predose 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 in each period |