To investigate the safety and pharmacokinetics of RGH-478

• Research type

  Research Study

• Full title

  A study to examine the Tolerability,Safety,and Pharmacokinetics of Single Oral Doses of RGH-478 in Healthy Male Volunteers.

• IRAS ID

  11961

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Gedeon Richter Plc.

• Eudract number

  2008-006708-42

• ISRCTN Number

  finished

• Research summary

  The drug being tested in this study is RGH-478. It is being developed to treat symptoms of inflammatory pain.This will be the first time RGH-478 will be tested in man.Extensive animal studies and laboratory tests have suggested that RGH-478 should be safe when given in the doses proposed in this trial. The study objective is to investigate the tolerability, safety and pharmacokinetics of a range of single oral doses of RGH-478 in healthy young male volunteers.The study will take place at Quintiles Limited, Guy's Drug Research Unit and will consist of two parts; Part 1 and Part 2.Part 1 will involve up to 3 cohorts of either 8 or 12 volunteers each. In this part of the study some volunteers will take dummy medicine instead of the study medicine but neither the volunteers nor the study staff will know which volunteer is taking the dummy dose. Part 2 will involve up to 2 cohorts of 12 healthy male volunteers and will investigate the effect of food on the way the body handles (absorbs, distributes, breaks down and excretes) RGH-478. All volunteers participating in this part of the study will receive study medicine only.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  08/H0803/225

• Date of REC Opinion

  11 Dec 2008

• REC opinion

  Further Information Favourable Opinion