Investigate the Safety, tolerability and pharmacokinetics of RO4995819

• Research type

  Research Study

• Full title

  A Single Center, Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of RO4995819 Following Oral Administration in Healthy Subjects.

• IRAS ID

  44356

• Contact name

  Darren Wilbraham

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2009-011624-62

• ISRCTN Number

  xx

• Research summary

  The drug being tested in this study, RO4995819, is being developed for the possible treatment of mood disorders such as depression. This will be the second study during which this drug will be given to human volunteers. This study plans to investigate the safety, tolerability, pharmacokinetics (how the body handles the drug) and pharmacodynamics (the effect of the drug on the body) of a range of multiple oral doses of RO4995819 in healthy volunteers. The study will take place at Quintiles Drug research Unit. Up to 40 volunteers, in 5 groups of 8 each (6 active; 2 placebo), will participate in the trial. Each volunteer will attend the unit for a single admission lasting 18 days, during which time they will receive RO4995819 on 18 occasions.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/4

• Date of REC Opinion

  18 Feb 2010

• REC opinion

  Further Information Favourable Opinion