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

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment

Conditions
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Hepatic Insufficiency

Intervention / Treatment
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* Drug: Evacetrapib


Participation Criteria
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Eligibility Criteria
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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

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 (Healthy)<br>Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function | Drug: Evacetrapib<br> <br> * Other names: LY2484595;|
| Experimental: Evacetrapib (Hepatic, Mild)<br>Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment | Drug: Evacetrapib<br> <br> * Other names: LY2484595;|
| Experimental: Evacetrapib (Hepatic, Moderate)<br>Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment | Drug: Evacetrapib<br> <br> * Other names: LY2484595;|
| Experimental: Evacetrapib (Hepatic, Severe)<br>Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment | 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 (AUC0-tlast) of Evacetrapib | tlast is defined as the last time point with a measurable concentration of Evacetrapib. | 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: Maximum Observed Concentration (Cmax) of Evacetrapib |  | 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 |  | 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 |