A Study of Evacetrapib (LY2484595) 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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-11-30

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.

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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

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Evacetrapib -- Solid Fraction Test

Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Evacetrapib -- Solid Fraction Reference

Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes