Absolute Bioavailability of Evacetrapib
Research type
Research Study
Full title
An Absolute Bioavailability Study of Evacetrapib in Healthy Subjects Using the Intravenous Tracer Method
IRAS ID
162883
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2013-004856-39
Research summary
Evacetrapib (Study Drug) is an investigational drug which is being developed to help people at high risk of heart problems in the future.
Heart problems can be caused by having high levels of ‘bad’ cholesterol (LDL-C) in the blood. When there are excessive levels of cholesterol in the blood, the cholesterol accumulates on the walls of the blood vessels and blocks them, causing heart problems.
Current treatments include aggressive lowering of a particular type of cholesterol (bad cholesterol, LDL-C) in the body or increasing another type of cholesterol (good cholesterol, HDL-C). By lowering the levels of bad cholesterol it reduces the amount of accumulation on the blood vessel walls and therefore reduces strain on the heart and heart problems. However, these treatments are not well tolerated, due to side effects patients experience when taking them. For this reason and also the lack of additional treatments available, a new treatment to raise the good cholesterol which is well tolerated, will improve the outcome of people at high risk of heart problems. The study drug is expected to increase the amount of good cholesterol in the body and may therefore offer another treatment to be used alone or in conjunction with LDL-C lowering treatments, for these patients.
In this study we will be comparing how much of the Study Drug gets into the blood stream when it is given as a single dose (in tablet form) and as an intravenous injection (given directly into a vein via a small needle). The injected Study Drug will be labelled with [13C8]. This means that a substance (Carbon 13) which is a naturally occurring alternative form of carbon, will be incorporated into the Study Drug to allow us to trace the 2 different administrations of Study Drug.
Subject participation is expected to last up to 6 weeks from the time of screening till the last post-study visit.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1221
Date of REC Opinion
20 Oct 2014
REC opinion
Further Information Favourable Opinion