Phase I bioavailability and safety of topical GF-001001-00

• Research type

  Research Study

• Full title

  GF-001001-00: A phase I, cross over, randomised study to examine the systemic bioavailability and safety of topical applications of 2% cream on intact and abraded skin in healthy volunteers

• IRAS ID

  41725

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Ferrer Internacional Ltd

• Eudract number

  2009-017246-32

• ISRCTN Number

  1

• Research summary

  Previous studies carried out in healthy males have shown that GF-001001-00 is safe and well tolerated when applied to the skin as 1% ointment and 2% cream. The purpose of this study is to investigate the safety and tolerability of GF-001001-00 and how much is absorbed by the body, when applied to intact skin or skin that has had the top layer removed by tape stripping (abraded skin). To do this, each volunteer will be given GF-001001-00 twice daily for 7.5 days over two treatment periods. In one treatment period, drug will be applied to intact skin. In the other treatment period, drug will be applied to abraded skin. Blood samples will be taken at set times for measurement of drug levels and side effects monitored. This will tell us whether there are any differences in the way that the body handles GF-001001-00 when applied to normal or abraded skin and any safety concerns or side effects that may occur. GF-001001-00 is being developed for the topical treatment of uncomplicated skin and skin structure infections. It is a new quinolone antibiotic that works by preventing bacteria from multiplying therefore stopping infection. It is more potent than currently available quinolone antibiotics. It is hoped that the development of topical GF-001001-00 will shorten the treatment period of skin infections, and reduce the risk of systemic side effects.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/5

• Date of REC Opinion

  2 Feb 2010

• REC opinion

  Further Information Favourable Opinion