Bioavailability and Pharmacokinetics of BC-3781 (QBR114346)

• Research type

  Research Study

• Full title

  A 5-Period Study in Healthy Subjects to Investigate the Relative Bioavailability and Pharmacokinetics of BC-3781 Prototype Formulations

• IRAS ID

  121039

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Forest Research Institute

• Eudract number

  2012-005153-23

• ISRCTN Number

  To be registered

• Research summary

  The Sponsor is developing BC-3781 an antibiotic for the potential treatment of bacterial skin infections and bacterial respiratory tract infections. The purpose of the research study is to see how is absorbed by the body. We also want to see how different forms or preparations of the study drug change the way the study drug are absorbed by the body. The different forms might change the speed or the timing for release of the study drug. Blood samples will be taken to look at the amount of study drug in the blood at different times to see how much of BC-3781 is absorbed by the body. By doing this study, we are hoping to identify the best tablet or capsule preparation of BC-3781. We will also look at any side effects that might occur after taking BC-3781 in order to make sure it is safe. A single group of 15 healthy adult male subjects will be recruited. There will be up to 5 study periods, and each subject will receive a different drug formulation in each period. Either a modified release drug formulation will be used, or a formulation containing fat. This will be decided following the results from a current study (BC3-PK-01). Subjects will receive five treatments, one of which will be a reference treatment (600 mg immediate release (IR) tablet). The remaining four treatments will be a 400mg lipidic Prototype or a 600mg modified release Prototype treatment. The subjects may be fasted or fed a high fat meal prior to treatment.

• REC name

  Wales REC 2

• REC reference

  13/WA/0013

• Date of REC Opinion

  18 Jan 2013

• REC opinion

  Favourable Opinion