A Study of Evacetrapib in Participants With Abnormal Cholesterol

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Evacetrapib: Multiple Dose 24 Weeks	Evacetrapib	Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
Evacetrapib: Multiple Dose 12 Weeks	Evacetrapib	Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
Evacetrapib: Single Dose	Evacetrapib	Single oral dose of evacetrapib on Day 1
Evacetrapib: Multiple Dose 52 Weeks	Evacetrapib	Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level	Day -1, Day 8