A PET study to assess brain uptake of SEP-380255 v1

• Research type

  Research Study

• Full title

  An Open-label, Positron Emission Tomography Study in Healthy Subjects to Investigate Dopamine D2 Receptor Occupancy of Oral Doses of SEP-380255 [(S)-amisulpride], using (+)-4-propyl-9-hydroxynaphthoxazine (11C-PHNO)(16-011)\n

• IRAS ID

  210990

• Contact name

  Frans van den Berg

• Contact email

  fvandenberg@hmrlondon.com

• Sponsor organisation

  Sunovion Pharmaceuticals Inc

• Eudract number

  2016-002303-25

• Duration of Study in the UK

  Publication of this data is currently deferred.

• Research summary

  Amisulpride is a medicine that’s prescribed by doctors to treat schizophrenia and mood disorders. It’s made up of 2 parts: (S)-amisulpride and (R)-amisulpride. We’re testing only (S)-amisulpride (or SEP-380255) in this study. Both schizophrenia and mood disorders are linked to chemical imbalances in the brain. The 2 parts of amisulpride may have different effects on those imbalances. We’re developing a new medicine based on (S)-amisulpride and (R)-amisulpride, that may be a good treatment for mood disorders. \n\nWe’re doing this study in up to 12 healthy volunteers, aged 25–45, to find out how well (S)-amisulpride works. We’ll measure how much (S)-amisulpride binds to sites in the brain, called dopamine receptors, using PET (positron emission tomography) scans, which make images of the brain. We’ll also assess blood levels of (S)-amisulpride, and whether it has any important side effects. \n\nParticipants will take a single dose of up to 600 mg (S)-amisulpride by mouth, and have up to 4 PET scans and 1 MRI (magnetic resonance imaging) scan. They’ll take up to 4 weeks to complete the study. They’ll have 2 screening visits, 2 study sessions, and 1 follow-up visit. They’ll stay on the ward for 1 night in the first study session and 2 nights in the second. \n\nBefore each PET scan, we’ll give participants an injection of radioactive tracer containing carbon-11; the tracer binds to dopamine receptors in the brain, and the PET scan shows where the tracer is. Participants will be exposed to radiation similar to 2.5 years’ background radiation. \n\nA pharmaceutical company called Sunovion Pharmaceuticals Inc is funding the study. \n\nThe study will take place at 1 research centre and 1 imaging centre in London. \n

• REC name

  London - Brent Research Ethics Committee

• REC reference

  16/LO/1267

• Date of REC Opinion

  6 Aug 2016

• REC opinion

  Favourable Opinion