A PET study in Japanese people to assess brain levels of RO5186582, v1

• Research type

  Research Study

• Full title

  A single-centre, non-randomised, open label, positron emission tomography imaging study to assess occupancy of alpha 5-containing GABAA receptors by RO5186582 in healthy volunteers of Japanese origin. (HMR code: 15-003)

• IRAS ID

  181369

• Contact name

  Adeep Puri

• Contact email

  apuri@hmrlondon.com

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  RO5186582 is an experimental medicine that we hope will improve memory and attention in people with Down Syndrome by targeting sites in the brain called GABA(A)α5 receptors.

  If this and future studies are successful, RO5186582 would be a useful treatment for patients in many countries, including Japan. But first, we need to test it in Japanese people, so that we can compare the results with those from other ethnic groups.
  We’re doing this study in up to 8 healthy Japanese men and women, aged 20–45 years, to measure how much RO5186582 attaches (‘binds’) to GABA(A)α5 receptors in the brain.

  Participants will attend up to 2 screening visits before the study, during which they’ll have an MRI (magnetic resonance imaging) scan. Eligible participants will then have 2 study sessions. In the first session, they’ll have 1 PET (positron emission tomography) scan; in the second session, they’ll take a dose of up to 960 mg RO5186582 and have 2 PET scans after their dose.

  Before each PET scan, we’ll give participants an injection of a radioactive tracer containing carbon-11; the PET scan shows where the tracer is in the brain, so we can tell where the receptor is and how much RO5186582 is binding it. Each participant will be exposed to radiation similar to 2 years’ background radiation.

  Participants will take up to 12 weeks to finish the study. They’ll stay on the ward for 1 night in each study session and make up to 3 outpatient visits.

  A pharmaceutical company, F. Hoffmann-La Roche Ltd (Roche), is paying for the study.

  The study will take place at a research unit and an imaging centre in London.

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  15/SS/0085

• Date of REC Opinion

  4 Jun 2015

• REC opinion

  Favourable Opinion