EIAW - Japanese DDI
Research type
Research Study
Full title
Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non Japanese Subjects
IRAS ID
136089
Contact name
Joseph Chiesa
Contact email
Sponsor organisation
Eli Lilly and Company Ltd
Eudract number
2013-002935-12
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Evacetrapib is a new drug being developed to help people at high risk of blood vessel problems that can lead to a heart or brain attack.
Cholesterol is required in the body to produce the membranes surrounding cells as well as to produce hormones, bile and Vitamin D. In the blood, cholesterol is carried around the body in shells made of fat and protein called lipoproteins. Lipoproteins of different densities are found in the body and are necessary to transport the cholesterol to different parts of the body. Having high levels of cholesterol contained in Low Density Lipoproteins (LDL Cholesterol) is a risk factor for problems including heart disease, having high levels of cholesterol contained within High Density Lipoproteins (HDL Cholesterol) does not increase the risk of these.
Current treatments to reduce the risk of heart disease lower the levels of LDL cholesterol, however these can be poorly tolerated. Evacetrapib is expected to increase the amount of HDL cholesterol, as well as decrease the LDL cholesterol, in the body and therefore offer another treatment for these patients.
This study will assess if evacetrapib affects the way that the body handles pravastatin, when both drugs are given at the same time. Pravastatin is a licensed drug that lowers LDL Cholesterol. It works by preventing the production of cholesterol by the liver and as a result reduces the total levels of cholesterol.
In previous studies, Japanese subjects have been shown to have higher levels of evacetrapib in the blood after dosing, compared to non-Japanese subjects.
The purposes of this Study are to further explore what effect evacetrapib has on pravastatin levels in the blood when given at the same time and to assess the tolerability of evacetrapib and pravastatin when given together to Japanese and non-Japanese people.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0433
Date of REC Opinion
7 Oct 2013
REC opinion
Further Information Favourable Opinion