Evaluation of Regional Delivery of BC-3781 (QBR114345)

• Research type

  Research Study

• Full title

  A 5 Period Study to Evaluate Regional Delivery and Formulation Challenges of BC 3781 Throughout the Gastrointestinal Tract in Healthy Subjects

• IRAS ID

  115786

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Forest Research Institute

• Eudract number

  2012-004038-41

• ISRCTN Number

  to be registered

• Research summary

  The Sponsor is developing the study drug, BC-3781, for potential use as an antibiotic with the ability to work throughout the entire body for the treatment of acute bacterial infections of the skin and skin structure infections and respiratory tract infections. The study will try to identify the bioavailability of the study drug, or how well the study drug is made present in the bloodstream, when absorbed in various regions of the gut. This study will dose BC-3781 at 400 mg to healthy male subjects over 5 study periods. In Period 1, the subjects will be dosed with the immediate release reference product as 2 x 200mg capsules. In Periods 2 and 3, they will be dosed with 400 mg of BC-3781 via Enterion capsule delivered to different regions of the gut. In Period 4, they will receive 400 mg of BC-3781 as a prototype oral formulation. In Period 5, following a review of safety and pharmacokinetic data, they will receive either: 400 mg of BC-3781 as a different prototype oral formulation, Regimen D at a different dose level, or Regimen D via an Enterion capsule and delivered to a targeted region of the gut (TBD).

• REC name

  Wales REC 2

• REC reference

  12/WA/0309

• Date of REC Opinion

  12 Oct 2012

• REC opinion

  Favourable Opinion