A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 10/10/2018 |
Start Date: | April 2013 |
End Date: | October 2013 |
Pharmacokinetics of Evacetrapib (LY2484595) Following Administration to Subjects With Impaired Renal Function
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.
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.
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
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