A Study of Evacetrapib in Participants With Abnormal Cholesterol
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/5/2018 |
| Start Date: | May 2014 |
| End Date: | December 2015 |
A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks
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.
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.
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
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