Safety, blood levels and brain uptake of GSK618334; version 1

• Research type

  Research Study

• Full title

  A placebo-controlled, single blind, randomized, two part study to investigate the tolerability, pharmacokinetics, and brain dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 for up to 21 days in healthy volunteers (09-009).

• IRAS ID

  30566

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd

• Eudract number

  2009-013918-27

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental treatment for addiction. We hope that it will work by blocking sites in the brain, called D3 receptors. We hope that the study medicine will reduce addicts?? craving, and have fewer side-effects than currently available medicines for addiction.The study is in 2 parts. In both parts We'll test repeated doses of the study medicine, to find out its side effects and blood levels. In Part 2, We'll also measure how much of the study medicine attaches (??binds?) to D3 receptors in the brain, using a PET (positron emission tomography) brain scan. We'll inject a tiny dose of a radioactive tracer. The tracer binds to D3 receptors in the brain, and the PET scan shows which part of the brain the tracer is.At least 40 healthy men and women will do Part 1, and up to 6 healthy men will do Part 2. Participants will be aged 18-50 years and will take up to 21 daily doses of study medicine. In Part 1, We'll start with a low dose, and increase the dose as the study progresses. Some people will take dummy medicine instead of the study medicine. We'll decide the doses for Part 2 after we??ve reviewed the results of Part 1.Participants will take up to 11 weeks to finish the study. They??ll make 2 outpatient visits, and stay on the ward for up to 27 nights.Healthy volunteers can??t benefit from the study medicine, but they might benefit from our screening tests, if we found an important problem.A pharmaceutical company, GlaxoSmithKline, is funding the study.The study will take place at 2 centres 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

  09/IEC02/19

• Date of REC Opinion

  4 Sep 2009

• REC opinion

  Favourable Opinion