QBR110996 (K-887-08)
Research type
Research Study
Full title
Pharmacokinetic Drug-Drug Interaction study between K-877 and Rosuvastatin in healthy male subjects
IRAS ID
79252
Contact name
Sharan Sidhu
Sponsor organisation
Kowa Research Europe Ltd
Eudract number
2011-001013-14
Research summary
The purpose of the study is to look at how the study drug (K-877) is handled by the body in the presence of another drug, when given together. The other drug in this study is known as rosuvastatin. Rosuvastatin is a medicine which is licenced for use in the UK and is commercially available as Crestor©.K-877 is being developed for the treatment of dyslipidemia (abnormal amounts of fatty material in the blood) which is one of the major causes of atherosclerotic disorders such as cardiac disease and cerebral vascular disease. Atherosclerosis is a condition in which fatty material builds up in arteries causing them to thicken and harden, and may eventually block the arteries.During development, K-877 has shown that it is effective in reducing the levels of fats in the blood, and it might be used in the future in patients taking rosuvastatin, which also has a beneficial effect on fats in the blood.This is an open label, 6-sequence, 3-treatment-period (7days) crossover study in healthy adult male subjects. There is a minimum 7-day washout period between each treatment administration. Subjects will return to the clinical unit 5-10 days after the last administration for a follow-up visit. Whether there is an interaction between K-877 and Rosuvastatin will be determined by comparing the concentrations of the drugs in the blood when given together to when the drugs are given alone. The safety and tolerability of K-877 will also be assessed in the study.. This study is being sponsored by Kowa Research Europe Ltd.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
11/IE/0048
Date of REC Opinion
19 May 2011
REC opinion
Further Information Favourable Opinion