Absorption & elimination of radiolabelled SK-0403 by humans; version 1

• Research type

  Research Study

• Full title

  Absorption, metabolism and excretion of 14C-SK-0403 in healthy men after a single oral dose (HMR code 08-009)

• IRAS ID

  6050

• Contact name

  Steve Warrington

• Sponsor organisation

  Sanwa Kagaku Kenkyusho Co, Ltd

• Eudract number

  2008-003797-18

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  In healthy people, blood sugar is controlled by a hormone called insulin. People with type 2 diabetes can produce insulin, but their bodies don??t respond fully to it, so their blood sugar is high. If diabetes isn??t treated, it can cause long-term health problems. We hope that the study medicine will increase levels of insulin, which will reduce blood sugar. Many medicines are already available to treat diabetes, but there??s still a need for new ones. In this study, We'll measure how the body breaks down and gets rid of the study medicine by ??labelling?? it with a small amount of radioactivity, so that we can detect tiny quantities of it in participants?? blood, urine and stools. The study is an important part of the development of the study medicine. 6 healthy men, aged at least 25 years, will take a single dose of study medicine that??s labelled with a small amount of radioactivity, called carbon-14. The amount of radioactivity will be equivalent to just under a fifth of the total amount of background radiation that the average UK resident is exposed to each year. Participants will stay on the ward for 7 days and 8 nights, and will take up to 4 weeks to finish the study. While they??re on the ward, participants will collect all their urine and stools, and We'll take many blood samples. Healthy volunteers can??t benefit from the study medicine, but they might benefit from our screening tests, if we found an important problem. A pharmaceutical company (Sanwa Kagaku Kenkyusho Co, Japan) is funding the study. The study will take place in a unit in London. We'll recruit participants by: advertising (newspapers, radio and websites); by word of mouth; from our volunteer database; and via our website.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  08/H0717/61

• Date of REC Opinion

  10 Oct 2008

• REC opinion

  Favourable Opinion