Study of Food on Evacetrapib (LY2484595) in Healthy Participants

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.

This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment

NCT01836185

Hepatic Insufficiency

COMPLETED PHASE1

A Study of LY3023414 Formulations and the Effect of Food

NCT02818335

Healthy

COMPLETED PHASE1

A Study of Evacetrapib in Healthy Japanese Participants

NCT02226653

Healthy Volunteers

COMPLETED PHASE1

A Study of LY2835219 in Healthy Participants

NCT02059148

Healthy Volunteers

COMPLETED PHASE1

A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants

NCT02271425

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Evacetrapib (Fasted)

130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Evacetrapib (Fed)

130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

High-fat Meal

Intervention Type OTHER

Administered orally, at breakfast.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evacetrapib

Administered orally

Intervention Type DRUG

High-fat Meal

Administered orally, at breakfast.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY2484595

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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/m²)
* Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

Exclusion Criteria

* Have known allergies to evacetrapib, 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
* Are participants who 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