Mass Balance Recovery, Metabolite Profile of [14C]-EVP-6124

• Research type

  Research Study

• Full title

  Open Label, Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-EVP-6124

• IRAS ID

  58180

• Contact name

  Stuart Mair

• Sponsor organisation

  EnVivo Pharmaceuticals, Inc.

• Eudract number

  2010-021066-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  EVP-6124 is being developed to enhance the cognitive function in patients with schizophrenia or Alzheimer??s disease. This study will provide information on the levels of EVP-6124 in the blood and how the body breaks down and eliminates EVP-6124. Six healthy men will participate, each will receive one 10 mg oral dose of [14C]-EVP-6124 (carbon 14[14C]) is a radiolabelled marker). After taking [14C]-EVP-6124 all urine and faeces will be collected, from which the radiolabelled marker Carbon 14 will be measured showing how much EVP-6124 is eliminated in urine and in faeces. As well as collecting urine and faeces, blood samples will be collected to measure the amount of EVP-6124 in the blood and plasma. Plasma will be also be analysed for breakdown products of EVP-6124, known as metabolites.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/26

• Date of REC Opinion

  1 Nov 2010

• REC opinion

  Further Information Favourable Opinion