To investigate increasing doses of ACT-334441

• 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 single and multiple increasing doses of ACT-334441 in healthy male and female subjects

• IRAS ID

  64553

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Actelion Pharmaceuticals Ltd

• Eudract number

  2010-021839-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The drug being tested in this trial is ACT-334441. It is being developed as a possible treatment of diseases associated with the immune system. This will be the first time this drug has been given to man. The purpose of this study is to examine the safety and tolerability of single and multiple increasing doses of ACT- 334441in healthy male and female volunteers. The way the body handles (absorbs, distributes, breaks down and excretes), oral (by mouth) doses of ACT-334441, is also being investigated. The study will take place at Quintiles Drug research Unit at Guy's Hospital. This study has 2 parts- Part A and Part B. Up to 48 healthy male volunteers will participate in Part A of the study and 16 healthy male and female volunteers will participate in Part B of the study. Each subject will participate in a screening period, one treatment period lasting for at least 8 days (Part A) and up to 5 weeks (Part B) and a study completion evaluation (between days 30 - 35 of the study). The information gained in this study will help the sponsor of this study to determine whether ACT-334441 is suitable for further studies in humans.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/32

• Date of REC Opinion

  8 Nov 2010

• REC opinion

  Further Information Favourable Opinion