BGC20-1531 AND IBUPROFEN INTERACTION STUDY

• Research type

  Research Study

• Full title

  An open-label, single dose, two-way crossover drug interaction study to assess the pharmacokinetics of oral ibuprofen when co-administered with BGC20-1531.

• IRAS ID

  17684

• Sponsor organisation

  BTG International Limited

• Eudract number

  2009-009883-30

• ISRCTN Number

  1

• Research summary

  Ibuprofen is a drug, available without prescription, commonly used to treat painful conditions such as headache. The purpose of this study is to investigate the effect of a new drug called BGC20-1531 on the concentrations of ibuprofen reached in the blood after a single dose of ibuprofen. BGC20-1531 is a new chemical entity (NCE) which is being developed for the treatment of migraine headaches. A previous study showed that BGC20-1531 blocked the enzyme thought to be involved in breaking down drugs such as ibuprofen. As migraine sufferers often require rescue medications such as ibuprofen, it is important to determine if BGC20-1531 has any effect on the blood levels of ibuprofen and at the same time assess the safety of giving both medicines together. The study will be conducted in a total of 16 healthy male subjects at Simbec Research Limited and will be of approximately 5 weeks in duration from screening to post study follow up visit.

• REC name

  Wales REC 1

• REC reference

  09/WSE04/9

• Date of REC Opinion

  9 Mar 2009

• REC opinion

  Favourable Opinion