V158866: first doses in humans; version 1

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of V158866 in healthy volunteers (HMR 10-019)

• IRAS ID

  73262

• Contact name

  Steve Warrington

• Sponsor organisation

  Vernalis (R&D) Ltd

• Eudract number

  2011-000063-27

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  V158866 is an experimental treatment for neuropathic pain, which is pain caused by damage to the nerves. We hope that V158866 will increase levels of a natural, cannabis-like pain-relieving substance in the body.We hope that V158866 will relieve pain, without the side-effects linked to cannabis use. V158866 has never been given to humans before. We want to find out its side effects, blood levels and effects. We-re doing this study in healthy men aged 18-45 years. It-s in 2 parts (A and B). * Part A:We'll test single doses of V158866 in 18 men * Part B:We'll test repeated doses of V158866 over 7 days in 32 menIn each part, We'll start with a small dose, then increase it as the study progresses. Participants in Part A will take 2 doses of V158866 and 1 dose of dummy medicine. Some Participants in Part B will take dummy medicine instead of V158866. Neither the Participants nor we will know which treatment they-ve been given. Participants in Part A will be in the study for up to 9 weeks. they'll have:3 study sessions (they'll stay on the ward for 4 nights in each session); and 2 outpatient visits.Participants in Part B will be in the study for up to 6 weeks. they'll have:1 study session (they'll stay on the ward for 10 nights); and 2 outpatient visits. A pharmaceutical company, Vernalis (R&D) Ltd, is funding the study. The study will take place at 1 centre in London.We'll recruit healthy Participants: by advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  Scotland A REC

• REC reference

  11/IE/0004

• Date of REC Opinion

  25 Feb 2011

• REC opinion

  Further Information Favourable Opinion