A PET study to assess brain uptake of RO5545965, version 1

• Research type

  Research Study

• Full title

  A Single Centre, Open Label Study to Characterize the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a Single Dose in Healthy Males Volunteers using [11C]IMA107 Positron Emission Tomography (HMR code: 13-004)

• IRAS ID

  133673

• Contact name

  Gary Peters

• Contact email

  gpeters@hmrlondon.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Eudract number

  2013-000538-36

• ISRCTN Number

  Not provided

• Clinicaltrials.gov Identifier

  Not provided

• Research summary

  RO5545965 is an experimental treatment for schizophrenia. Schizophrenia may cause hallucinations and paranoia (‘positive symptoms’); lack of drive, and social withdrawal (‘negative symptoms’); and problems with memory and attention (‘cognitive symptoms’).

  We hope that RO5545965 will relieve the symptoms of schizophrenia by blocking a substance called Phosphodiesterase 10A (PDE10A) in the brain. We hope that it will work better, and have fewer side effects, than existing treatments.

  Up to 16 healthy men, aged 25–50, will take a single dose of RO5545965, and have PET (positron emission tomography) scans to measure how much RO5545965 attaches to PDE10A in the brain. During each PET scan, participants will receive a small dose of radioactive tracer (containing carbon-11) by injection. The tracer binds to PDE10A in the brain, and the PET scan shows where the tracer is.

  Each participant will have 3 PET scans: one before the dose of RO5545965, and 2 after dosing. They’ll be exposed to just over twice the total amount of natural background radiation that the average UK resident is exposed to each year. That amount of radiation is a negligible risk to health. Participants will also have one MRI (magnetic resonance imaging) scan of their brain.

  Participants will take up to 8 weeks to finish the study. They’ll stay on the ward for 3 nights, make 3 outpatient visits, and have 1 follow-up phone call.
  A pharmaceutical company, F. Hoffmann-La Roche Ltd, is funding the study.

  The study will take place at a research unit and a scanning unit in London. We’ll recruit healthy participants by: advertising (newspaper, radio and websites); word of mouth; volunteer databases; and our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/0918

• Date of REC Opinion

  5 Jul 2013

• REC opinion

  Favourable Opinion