QBR110346

• Research type

  Research Study

• Full title

  An Open Label, Single-Dose, Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolic profile and metabolite Identification of [14C]BF2.649

• IRAS ID

  83303

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Bioprojet Pharma

• Eudract number

  2011-002340-27

• Research summary

  BF2.649 is being developed as an oral dosage form. It is a novel, highly potent, selective, orally active histamine H3 receptor antagonist. When given orally or into a vein, BF2.649 enhances transmissions in the brain and thereby improves concentration, learning and memory and displays pro-cognitive (reduction of confusion and disorientation) properties. BF2.649 showed strong waking effects on experimental models of narcolepsy and Parkinson's disease (PD). Animal studies indicate that BF2.649 is effective on models of schizophrenia and could have a beneficial effect on typical absence epilepsy in humans. The primary aim of this study is to define the absorption and excretion routes of [14C]BF2.649 in humans following oral administration, and to investigate the nature of the metabolites (break down products) present in blood serum , urine and faeces.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0132

• Date of REC Opinion

  27 Sep 2011

• REC opinion

  Further Information Favourable Opinion