A Study of the Blood Levels of BGC20-1531 (Final, dated 04 August 09)

• Research type

  Research Study

• Full title

  An open-label, single dose, randomised, two-way crossover study to assess the pharmacokinetics and bioequivalence of oral BGC20-1531 from two batches of BGC20-1531 capsules.

• IRAS ID

  29485

• Sponsor organisation

  BTG International Ltd

• Eudract number

  2009-014609-15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  BGC20-1531 is a small chemical which is being developed for the treatment of migraine headaches. A new batch of BGC20-1531 capsules has recently been made by the drug company. However, tests have been shown that these might dissolve a little more slowly than capsules from the earlier batch of BGC20-1531. This study is to compare the blood levels obtained with the new BGC20-1531 capsules to the blood levels achieved with the capsules from the earlier batch. This will be done by giving a single dose of the old and new batches on different occasions. Blood samples will then be taken at intervals to measure how much drug is found in the blood. In common with the previous studies, this study will also assess the safety of BGC20-1531.The study will be conducted in 18 healthy males who will be required to attend a screening visit up to 2 weeks before the study starts (to confirm eligibility), followed by 2 study periods set a week apart and each lasting approximately 1.5 days. A post study/safety follow-up will take place 3-7 days after the last study procedure. The visits in total, amount to a maximum of 4 weeks.

• REC name

  Wales REC 1

• REC reference

  09/WSE04/42

• Date of REC Opinion

  28 Sep 2009

• REC opinion

  Further Information Favourable Opinion