QBR106375 (K-877-07)

• Research type

  Research Study

• Full title

  EVALUATION OF ABSORPTION, METABOLISM AND EXCRETION OF 14C-K-877 AND ESTIMATION OF THE ABSOLUTE BIOAVAILABILITY OF K-877 IN HEALTHY MALE SUBJECTS

• IRAS ID

  81291

• Sponsor organisation

  Kowa Research Europe Ltd

• Eudract number

  2011-001361-41

• Research summary

  The purpose of this study is to define the absorption, breakdown and excretion (removal from the body) of a single dose of radiolabelled K-877 and its breakdown products when it is given as both an oral tablet, and as an injection into a vein. K-877 is being developed for the treatment of dyslipidemia/hypertriglyceridemia which is one of the major causes of atherosclerotic disorders such as cardiac disease and cerebral vascular disease.During development, K-877 has shown that it is effective in reducing the levels of triglycerides in the blood to prevent the onset of cardiovascular disease.The study will also provide additional safety information on how the body responds to K-877. This will be done by collecting laboratory test results, including the results of multiple blood tests, electrocardiograms, checking heart rate, body temperature and blood pressure and by recording any side effects that may occur throughout the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0082

• Date of REC Opinion

  30 Jun 2011

• REC opinion

  Further Information Favourable Opinion