Evaluation of [14C]-SD-809 and [14C]-Tetrabenazine in HV's (QBR113049)

• Research type

  Research Study

• Full title

  An Open-Label, Two-Period Study Designed to Evaluate and Compare the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of Oral Doses of Both [14C]-SD-809 and [14C]-Tetrabenazine in Healthy Male Subjects

• IRAS ID

  108895

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Auspex Pharmaceuticals, Inc.

• Eudract number

  2012-002137-10

• Research summary

  The Sponsor is developing the study drug, SD-809, for the potential treatment of chorea (abnormal involuntary movement) associated with Huntingdon's disease (degenerative neurological disease affecting muscle coordination). The comparator, Tetrabenazine, is currently approved in the UK, several EU countries, Australia and the US for the treatment of this indication. The study will compare how the investigational product and tetrabenazine are broken down by the body and determine how much of each drug taken is present in blood and eliminated in urine and faeces. This study will dose 2 cohorts of 6 healthy male subjects with an oral dose of 25 mg of either [14C]-SD-809 or [14C]-tetrabenzine in the fasted state. Blood, urine and faecal samples will be taken.

• REC name

  HSC REC A

• REC reference

  12/NI/0095

• Date of REC Opinion

  6 Jul 2012

• REC opinion

  Further Information Favourable Opinion