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

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of Evacetrapib (LY2484595) Following Administration to Subjects With Impaired Renal Function

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Evacetrapib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evacetrapib (Participants With Renal Impairment)<br>Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment. | Drug: Evacetrapib<br> <br> * Other names: LY2484595;|
| Experimental: Evacetrapib (Healthy Participants)<br>Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function. | Drug: Evacetrapib<br> <br> * Other names: LY2484595;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib |  | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose | 
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib |  | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib |  | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose |