To investigate the effect of AZD3161 on mechanical pain sensitivity

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Determine the Effect of Intradermal AZD3161 on Quantitative Sensory Testing Variables in Normal and UVC Exposed Skin in Healthy Volunteers

• IRAS ID

  65981

• Contact name

  Marianne Kasti

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-022832-35

• Research summary

  This is a single site phase I methodology study to investigate the effect of AZD3161 on mechanical pain sensitivity in normal and ultraviolet C irradiated skin. The purpose of this study is to investigate a product called AZD3161 which is a drug designed to reduce pain signals in nerves. The study will aim to test whether intradermal injection (superficial injection in the upper layer of skin) of AZD3161 reduces pain sensation and inflammation in skin exposed to UVC (Ultra-Violet C) radiation and in non-irradiated skin. It is anticipated that AZD3161 may be useful in different types of pain such as neuropathic pain (pain caused by nerve degenerating conditions such as diabetes) or nociceptive pain (pain caused by direct injury to body tissue) and this study may help decide whether this drug can go on to help such patients. An initial pilot group of 6 healthy subjects will be recruited prior to the main part of this study. The pilot group will undergo the same procedures as the main study but will not receive AZD3161. The pilot group will then be followed by the main group of the study that will involve approximately 20 healthy males and sterile women aged between 18 and 55 years old. The study will involve 3 visits to the Unit. Visit 1 will be the screening visit, Visits 2-5 will be the dosing visits and Visit 6 will be the follow-up visit. The study centre will be Quintiles Drug Research Unit at Guy's Hospital in London, United Kingdom.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/82

• Date of REC Opinion

  18 Nov 2010

• REC opinion

  Further Information Favourable Opinion