To evaluate excretion, metabolism & pharmacokinetics of 14C-AZD 6765

• Research type

  Research Study

• Full title

  A Phase I, Open-label, Single-Centre Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 after a Single-Dose Intravenous Administration to Healthy Male Subjects.

• IRAS ID

  59810

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-021553-39

• ISRCTN Number

  xx

• Research summary

  The drug being tested in this study is AZD6765. It is being developed as a possible treatment for Major depression disorder (MDD). Major depression disorder (MDD) is a mental disorder characterized by an all-encompassing low mood accompanied by low self-esteem, and by loss of interest or pleasure in normally enjoyable activities. People who experience major depression feel persistently sad. Other physical and mental problems often experienced include sleep problems, loss of appetite, inability to concentrate, memory problems, and aches and pains. People who suffer from this condition often feel worthless, helpless, and hopeless about their ability to fix things. This will not be the first time this drug has been given to human volunteers. The purpose of this research study is to investigate what AZD6765 is broken down into and how quickly by analysing blood, faeces and urine samples collected during the study. In this study AZD6765 is joined with radioactive carbon. This allows us to track tiny quantities of the drug and its breakdown products and determine how long they remain in the body. By measuring the drug in faeces and urine we can determine how the drug is eliminated from the body. We may also want to investigate how genetic variations may fluence the way subject responds to AZD6765. The study will take place at Quintiles Drug Research Unit at Guy’s Hospital, Quintiles Ltd. The study involves 3 visits to the research unit, with a pre-study screening visit and a post-study follow-up visit. The study is expected to involve a total of 6 healthy volunteers. The information gained in this study will help the sponsor of this study to determine whether AZD6765 is suitable for further studies in humans.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/55

• Date of REC Opinion

  23 Aug 2010

• REC opinion

  Further Information Favourable Opinion