To investigate the safety and pharmacokinetics of AZD6088

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 after Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers

• IRAS ID

  23866

• Eudract number

  2008-007936-17

• ISRCTN Number

  xx

• Research summary

  The drug being tested in this study is AZD6088. It is being developed for the treatment of neuropathic pain (i.e. pain caused by injury to peripheral nerves or the central nervous system, which is often severe, chronic and difficult to treat adequately). Currently available treatments for neuropathic pain have limited efficacy as well as a high incidence of side effects, hence the interest in developing potential new medications.This will be the first time AZD6088 has been tested in humans.The purpose of this research study is to determine the safety and tolerability of AZD6088. In addition, we will estimate how much AZD6088 enters the blood circulation by collecting blood and urine samples from subjects during the study.We are also investigating what the drug is broken down into, when given orally (by mouth) and (optionally) the presence or absence of certain genes that may affect the way the body handles AZD6088. The study will take place at Guy's Drug Research Unit, Quintiles Ltd. The study involves a 3 night residency in a research unit, with a pre-study screening visit and a post-study follow-up visit. The study is expected to involve a total of 64 volunteers. The information gained in this study will help the sponsor of this study to determine whether AZD6088 is suitable for further studies in humans.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/74

• Date of REC Opinion

  5 Jun 2009

• REC opinion

  Favourable Opinion