A Study of Evacetrapib in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to determine whether concentrations of the study drug (evacetrapib) in the blood stream is the same or is different when the person is also taking gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in combination. There is no washout period between doses. The safety of both of the study drugs given together will be evaluated. Information about any side effects that may have occurred will also be collected. This study will last approximately 36 days.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Gemfibrozil

Single oral dose of 600 milligrams (mg) gemfibrozil on Day 1

Group Type EXPERIMENTAL

Gemfibrozil

Intervention Type DRUG

Evacetrapib

Oral doses of 130 mg evacetrapib once a day (QD) for 10 days (Day 2 through Day 12)

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Evacetrapib + Gemfibrozil

Oral doses of 600 mg gemfibrozil twice a day (BID) and 130 mg evacetrapib QD for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Gemfibrozil

Intervention Type DRUG

Interventions

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Evacetrapib

Intervention Type DRUG

Gemfibrozil

Intervention Type DRUG

Other Intervention Names

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LY2484595

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/m\^2)

Exclusion Criteria

* Have known allergies to evacetrapib and gemfibrozil, 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
* Currently smoke cigarettes or use tobacco or nicotine substitutes

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes