Completed

Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Evacetrapib

+ Evacetrapib

+ Evacetrapib

Drug
Who is being recruted

Digestive System Diseases

+ Liver Diseases

+ Hepatic Insufficiency

From 18 to 85 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: October 12, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01836185
Principal SponsorEli Lilly and Company
Last updated: October 12, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesHepatic Insufficiency

Criteria

5 inclusion criteria required to participate
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)
Show More Criteria
4 exclusion criteria prevent from participating
Consumes excessively large amounts of drinks with caffeine or alcohol
Has had esophagus variceal bleeding within 3 months of check-in
Have evidence of cancer in the liver
Have the need to take medications that may interfere with how the liver removes the drug

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Miami, United StatesOpen For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. in Google Maps

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Orlando, United States
Completed2 Study Centers