A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Cardiovascular Disease

Treatments

Drug: Evacetrapib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01825889

14620

I1V-MC-EIAR (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment compared to participants with normal renal (kidney) function. This study will last approximately 8 weeks.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female participants are not of child-bearing potential
Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2)
Participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance [CLcr] greater than or equal to 90 milliliters per minute [mL/min] at screening)
Participants with severe renal impairment - estimated CLcr less than 30 mL/min at screening and are not undergoing hemodialysis

Exclusion criteria

Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Participants who are unwilling to comply with the dietary requirements/restrictions during the study
Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease