A PET study to assess brain uptake of SEP-4199; version 1

• Research type

  Research Study

• Full title

  An Open-label, Positron Emission Tomography Study in Healthy Subjects to Determine Prolactin Pharmacodynamic and Dopamine D2 Receptor Occupancies of Timed Administrations of Oral Solutions of a Fixed 85:15 Ratio of SEP-4199 (85% R-amisulpride: 15% S-amisulpride), using (+) 4 propyl 9 hyrdoxynaphthoxazine (11C-PHNO)(17-011)

• IRAS ID

  236473

• Contact name

  Frans van den Berg

• Contact email

  rec@hmrlondon.com

• Sponsor organisation

  Sunovion Pharmaceuticals Inc

• Eudract number

  2017-003996-67

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Amisulpride is a medicine that’s prescribed by doctors to treat schizophrenia and mood disorders. It is made up of equal amounts of S-amisulpride and R-amisulpride. Those 2 parts have different effects on different sites in the brain. We’re developing a medicine called SEP-4199 based on a new ratio of both parts that may be a good treatment for mood disorders.\n\nWe’re doing this study in up to 24 healthy volunteers, aged 25–45, to find out how well SEP-4199 binds to sites in the brain, called dopamine receptors, when it’s taken at regular intervals throughout the day. We’ll assess that using PET (positron emission tomography) scans, which make images of the brain. We’ll also measure the blood levels of SEP 4199 and substances related to SEP 4199, and monitor participants for important side effects.\n\nParticipants will take a dose of up to 600 mg SEP 4199 by mouth. We’ll split each dose into up to 24 smaller ‘portions’ which will be taken at regular intervals within a 6 hour period. Participants will have up to 3 PET scans and 1 MRI (magnetic resonance imaging) scan. They’ll take up to 6 weeks to complete the study. They’ll have 3 outpatient visits and stay on the ward for 4 nights in total (1 night on 1 occasion and 2 nights on another). \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 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

  17/LO/1809

• Date of REC Opinion

  9 Nov 2017

• REC opinion

  Favourable Opinion