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

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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evacetrapib

Drug

Other names: LY2484595

Primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib

Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose

tlast is defined as the last time point with a measurable concentration of Evacetrapib.
PK: Maximum Observed Concentration (Cmax) of Evacetrapib

Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib

Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Apr 19, 2013
Registry last updated: Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed