Pharmacokinetic study of BG00012 in subjects with Multiple Sclerosis

• Research type

  Research Study

• Full title

  A 24-hour Pharmacokinetic Determination of BG00012 after single day oral administration in subjects with Multiple Sclerosis.

• IRAS ID

  12856

• Sponsor organisation

  Biogen Idec Inc.

• Eudract number

  2008-006296-69

• Research summary

  BG00012 is a new medicine being developed for treating multiple sclerosis (MS) and has previously been studied for the treatment of psoriasis. MS is an autoimmune disease where the body??s own immune system attacks parts of the nervous system. BG00012 consists of dimethyl fumarate (DMF), which appears to affect different parts of the body??s immune system, and may aid a cell??s defence against stress and inflammation. BG00012 has previously been given to healthy volunteers, subjects with MS, subjects with psoriasis and is currently being studied in two ongoing global studies that will involve over 2000 patients. This study will evaluate the absorption (where the drug goes in the body), metabolism (how the body breaks the drug down) and excretion (how the body removes the drug) of BG00012 by measuring the amount of monomethyl fumarate (MMF), the major breakdown product of BG00012, in blood.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/10

• Date of REC Opinion

  16 Mar 2009

• REC opinion

  Further Information Favourable Opinion