Blood levels of YF476, given by mouth and by injection;version A

• Research type

  Research Study

• Full title

  A study to investigate the absolute bioavailability of YF476 using an intravenous microdose and oral 100 mg dose in healthy volunteers. (HMR code 05-029)

• IRAS ID

  26166

• Contact name

  Steve Warrington

• Sponsor organisation

  Hammersmith Medicines Research

• Eudract number

  2009-013258-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  YF476 is an experimental treatment for diseases of the stomach, such as indigestion caused by backflow of stomach juices into the gullet (called Ó?acid flu?). YF476 works by blocking the effects of gastrin - a hormone that triggers acid production by the stomach.We??ve made a new preparation of YF476. We??re doing this study in healthy people to find out exactly how much YF476 is absorbed into the bloodstream when people take the new preparation by mouth. We'll give 6 healthy men and women, aged 18-65 years, the new preparation by mouth, and a dose of YF476 by injection into a vein, then compare the blood levels.The dose of YF476 that we give by injection will be tiny (a Ó?microdose?). It will be labelled with a very small amount of radioactivity (carbon-14).Participants will take up to 5« weeks to finish the study. They??ll make 2 outpatient visits, and stay on the ward for 2 nights.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, TRIO Medicines Ltd, is funding the study.The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  09/H0717/36

• Date of REC Opinion

  3 Jul 2009

• REC opinion

  Favourable Opinion