Safety, blood levels and effects of repeated doses of GSK1034702; v1

• Research type

  Research Study

• Full title

  A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects (09-002).

• IRAS ID

  19200

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2008-007759-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental new treatment for poor mental function in diseases such as Alzheimer??s and schizophrenia. People with those diseases have problems with their memory, judgment and understanding, and may experience confusion and mood swings. We hope that the study medicine will work by mimicking the effects of a substance in the brain that??s at low levels in patients with poor mental function. We also hope that it??ll work better, and have fewer side effects, than existing medicines. We'll test repeated doses of the study medicine, to find out its: side effects; blood levels; effects on memory, attention, and problem-solving skills; and effects on saliva production. also test whether the study medicine affects the breakdown of dextromethorphan (a medicine for cough), and We'll study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine. We'll give up to 28 daily doses to each of 48 healthy men and women, aged 18-64 years. We'll start with a low dose, and increase the dose as the study progresses. Some participants will take dummy medicine instead of the study medicine - neither they nor we will know which one they??re taking. Participants will take up to 10« weeks to finish the study. They??ll make up to 6 outpatient visits, and stay on the ward for up to 32 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 1 centre in London. We'll recruit healthy participants by: advertising (newspaper and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/14

• Date of REC Opinion

  24 Aug 2009

• REC opinion

  Further Information Favourable Opinion