To investigate multiple doses of RGH-478

• Research type

  Research Study

• Full title

  A STUDY TO EXAMINE THE TOLERABILITY, SAFETY AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF RGH-478 IN HEALTHY MALE VOLUNTEERS

• IRAS ID

  29717

• Sponsor organisation

  Gedeon Richter Plc.

• Eudract number

  2009-014116-35

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  The drug being tested in this study is RGH-478, being developed to treat symptoms of inflammatory pain, as in diseases like Rheumatoid Arthritis and Osteoarthritis. This will be the second study during which this drug will be given to human volunteers. RGH-478 has been administered to 41 healthy male subjects in single doses in a study recently completed. This study plans to investigate the tolerability, safety and pharmacokinetics of a range of multiple oral doses of RGH-478 in healthy young male volunteers.The study will take place at Quintiles Limited, Guy's Drug Research Unit. Up to 72 volunteers, in 6 groups of 12 each will participate in the trial. Each volunteer will attend the unit for a single admission lasting at least 18 days, during which time they will receive RGH-478 on 24 occasions.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/78

• Date of REC Opinion

  14 Sep 2009

• REC opinion

  Further Information Favourable Opinion