A study of the safety, tolerability and handling of Dexpramipexole

• Research type

  Research Study

• Full title

  A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects

• IRAS ID

  83423

• Sponsor organisation

  Biogen Idec Ltd

• Eudract number

  2011-002045-34

• Research summary

  Dexpramipexole (BIIB050) is being developed by Biogen Idec, (the Sponsor, a pharmaceutical company based in Cambridge, Massachusetts, United States) and this study is being carried out on behalf of the Sponsor by Quintiles.Dexpramipexole is a drug that may be useful in the treatment of a form of motor neuron disease. Motor neuron disease is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscle activity including speaking, walking, breathing, swallowing and general movement of the body. It causes severe disability and people with the disease normally die as a result of it within 5 years of the start of symptoms. Unfortunately there is no known cure. The purpose of this study is to examine the safety and tolerability of single and multiple doses of dexpramipexole in healthy male and female, Japanese and Caucasian subjects. The study will be composed of three treatment periods: Treatment Period 1 and 2 with single, and Treatment Period 3 with multiple doses of dexpramipexole. Possible differences in the way the body handles (absorbs, distributes, breaks down and excretes), oral (by mouth) doses of dexpramipexole in Japanese and Caucasian volunteers, is also being investigated.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/0851

• Date of REC Opinion

  19 Jul 2011

• REC opinion

  Further Information Favourable Opinion