Crossover Study to Evaluate SD-809 and Tetrabenazine on QT Interval

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND POSITIVE-CONTROLLED CROSSOVER STUDY TO EVALUATE THE EFFECTS OF SINGLE DOSES OF SD-809 (DUTETRABENAZINE) AND TETRABENAZINE ON THE CORRECTED QT INTERVAL.

• IRAS ID

  160817

• Contact name

  Adrian Johnston Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Auspex Pharmaceuticals, Inc

• Eudract number

  2014-002843-16

• Research summary

  This is a Study in healthy volunteers evaluating the effects of single doses of SD-809 and tetrabenazine on the QTc interval on ECGs. The clinical indication is the treatment of abnormal movements associated with Huntington's disease. The Clinical trial will involve 48 healthy male and female participants at one Clinical Trial Site in the UK. The Clinical Trial is expected to last approximately 3 months.

• REC name

  HSC REC A

• REC reference

  14/NI/1039

• Date of REC Opinion

  12 Aug 2014

• REC opinion

  Further Information Favourable Opinion