RO5186582 – repeated doses; version 1

• Research type

  Research Study

• Full title

  A Single-Center, Randomized, Double-Blind, Multiple-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability and Pharmacokinetics of RO5186582 in Young Healthy Subjects, Following Oral Administrations (HMR code: 10-015)

• IRAS ID

  62476

• Contact name

  Steve Warrington

• Eudract number

  2010-021554-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  RO5186582 is an experimental new medicine for treating Alzheimer’s disease. People with Alzheimer’s have problems with their memory, judgment and understanding, and they may become confused or have rapid changes of mood. Alzheimer’s gets worse slowly, and there??s no cure for it. Some medicines improve the symptoms, but they don’t work for everyone, they have unpleasant side effects, and their effects wear off. We hope that RO5186582 will work by targeting sites in the brain called GABA-A receptors, which are linked to learning and memory. We hope that RO5186582 will work better, and have fewer side effects, than existing medicines for Alzheimer patients. We'll test repeated doses of RO5186582, to find out its side effects, blood levels, and effects on sleep. We'll also study how genes (pieces of DNA) affect the way the body responds to or handles RO5186582. We'll give 24 healthy men, aged 18??45 years, twice-daily doses for 13 days. We'll start with a low dose, and increase the dose as the study progresses. Some participants will take placebo, according to a code kept in sealed envelopes. Participants will take up to 8 weeks to finish the study. They'll make 2 outpatient visits, and stay on the ward for 17 nights. When they’re on the ward, we’ll take blood samples and do standard safety tests. To measure the effects of RO5186582 on sleep, we’ll do EEGs (a painless test that records the electrical activity of the brain) overnight and ask participants to complete questionnaires. A pharmaceutical company (Roche Products Limited) 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

  London - Harrow Research Ethics Committee

• REC reference

  10/H0709/64

• Date of REC Opinion

  14 Sep 2010

• REC opinion

  Favourable Opinion