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

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-10-31

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 bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. This study will last approximately 28 days, not including screening.

Related Clinical Trials

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

Study of Food on Evacetrapib (LY2484595) in Healthy Participants

NCT01810432

Healthy Volunteers

COMPLETED PHASE1

A Study of LY3314814 in Participants With Liver Impairment

NCT03499041

Hepatic Impairment

WITHDRAWN PHASE1

A Study of LY3437943 in Participants With Impaired and Normal Liver Function

NCT05916560

Healthy Hepatic Insufficiency

COMPLETED PHASE1

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

NCT02271425

Healthy Volunteers

COMPLETED PHASE1

A Study of LY2216684 in Participants With Impaired Hepatic Function

NCT01241435

Depressive Disorder, Major

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.

Hepatic Insufficiency

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 (Healthy)

Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Evacetrapib (Hepatic, Mild)

Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Evacetrapib (Hepatic, Moderate)

Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Evacetrapib (Hepatic, Severe)

Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Interventions

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

Evacetrapib

Intervention Type DRUG

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

* Participants have given written informed consent approved by the ethical review board (ERB) governing the site
* Female participants should be of non-childbearing potential
* Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m\^2)
* Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
* Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion Criteria

* Has had esophagus variceal bleeding within 3 months of check-in
* Have the need to take medications that may interfere with how the liver removes the drug
* Have evidence of cancer in the liver
* Consumes excessively large amounts of drinks with caffeine or alcohol

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes