Status:
COMPLETED
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
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 sev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01825889
Start Date
April 1 2013
End Date
October 1 2013
Last Update
October 9 2018
Active Locations (3)
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1
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, 33014
2
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, Florida, United States, 32806
3
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.
Saint Paul, Minnesota, United States, 55114