QBR110528

• Research type

  Research Study

• Full title

  A PHASE 1, RANDOMISED, CROSSOVER STUDY TO INVESTIGATE THE EFFECT OF ALCOHOL ON THE BIOAVAILABILITY OF GET 73 AND ITS MAJOR METABOLITE MET2 IN HEALTHY SUBJECTS

• IRAS ID

  83072

• Contact name

  Philip Evans

• Sponsor organisation

  Laboratorio Farmaceutico CT

• Eudract number

  2011-002354-31

• Research summary

  GET 73 is being developed by Laboratorio Farmaceutico CT as a potential treatment for alcohol abuse and has already been investigated as an oral (by mouth) form in 60 people in a First-In-Human study after single and repeated dosing. The compoundhas been well tolerated without significant adverse events. The purpose of the study is to see how drinking alcohol affects the way that the study drug is absorbed by the body, after single and multiple administrations. The safety and tolerability of the test drug will also be assessed.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0100

• Date of REC Opinion

  3 Aug 2011

• REC opinion

  Further Information Favourable Opinion