To investigate increasing doses of ACT-128800

• Research type

  Research Study

• Full title

  A Single-center, double-blind, placebo-controlled, randomized, parallel-group, up-titration study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of increasing doses of ACT-128800 in healthy male and female subjects.

• IRAS ID

  44245

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Actelion Pharmaceuticals Ltd

• Eudract number

  2009-017708-97

• ISRCTN Number

  requested

• Research summary

  The drug being tested in this trial is ACT-128800. It is being developed as a possible treatment of diseases associated with an overreaction of the immune system (e.g. psoriasis, multiple sclerosis). This will not be the first time the drugs will be given to man. ACT-128800 has been tested in studies involving healthy male and female volunteers. It has also been studied in patients with psoriasis and multiple sclerosis. The purpose of this study is to examine the safety and tolerability of multiple increasing doses of ACT-128800 in healthy male and female volunteers. The way the body handles (absorbs, distributes, breaks down and excretes) oral (by mouth) doses of ACT-128800 is also being investigated. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. 16 healthy subjects (male and female) will be enrolled onto the study Each subject will participate in a screening period, one treatment period lasting for at least 20 days and a study completion evaluation (10 days after the last dosing). Each Subject will receive six different dose levels. The information gained in this study will help the sponsor of this study to determine whether ACT-128800 is suitable for further studies in humans.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/7

• Date of REC Opinion

  25 Mar 2010

• REC opinion

  Further Information Favourable Opinion