A Study of Evacetrapib in Participants With Abnormal Cholesterol

Study Overview
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Brief Summary
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The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected. This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.

Official Title
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A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Evacetrapib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria: Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR Hypercholesterolemia on stable statin therapy for at least 3 month Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening Exclusion Criteria: Have known allergies or intolerance to evacetrapib, related compounds Have history of recurrent rashes or chronic skin conditions Have significant history of or current chronic, active inflammatory conditions Have history or current evidence of significant neurological disorder Have long-standing diabetes that is insulin requiring Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evacetrapib: Single Dose<br>Single oral dose of evacetrapib on Day 1 | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib: Multiple Dose 12 Weeks<br>Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib: Multiple Dose 24 Weeks<br>Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib: Multiple Dose 52 Weeks<br>Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) |  | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose | 
| PK Parameters of Evacetrapib: Maximum Concentration (Cmax) |  | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose | 
| PK Parameters of Evacetrapib: Terminal Half-life |  | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level |  | Day -1, Day 8 | 
| PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level |  | Day -1, Day 8 | 
| PD Parameters of Evacetrapib: Total Cholesterol Level |  | Day -1, Day 8 | 
| PD Parameters of Evacetrapib: Triglyceride Level |  | Day -1, Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abnormal cholesterol