A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-11-30

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Evacetrapib Reference (R)

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

administered orally

Evacetrapib Test 1 (T1)

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

administered orally

Evacetrapib Test 2 (T2)

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

administered orally

Interventions

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Evacetrapib

administered orally

Intervention Type DRUG

Other Intervention Names

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LY2484595

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes