A PSG study in healthy volunteers after single oral dose sep-380262 v1
Research type
Research Study
Full title
A Single-blind, Placebo-controlled, 2-Stage, 2-Way, Crossover, In-clinic, Polysomnographic (PSG) Study of a Single Oral Dose of SEP-380262 [(R)-amisulpride] in Healthy Adult Subjects (16-012)
IRAS ID
210993
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Sunovion Pharmaceuticals Inc
Eudract number
2016-002304-80
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: (R)-amisulpride and (S)-amisulpride. We’re testing only (R)-amisulpride (or SEP-380262) 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 (R)-amisulpride and (S)-amisulpride, that may be a good treatment for mood disorders. \n\nWe’re doing this study in up to 30 healthy volunteers, aged 18–45, to find out how well (R) amisulpride works. We think the study medicine enters the brain and attaches itself (‘binds’) to sites called serotonin receptors. Other medicines that work by regulating serotonin are known to affect the quality of sleep in some people. So, we’ll check whether the study medicine affects quality of sleep by doing a test called a polysomnography (PSG), which records the electrical activity of the brain, and monitors heart rate and rhythm, muscle activity, eye movements and breathing during sleep. We’ll also assess blood levels of (R)-amisulpride, and whether it has any important side effects. \n\nParticipants will take by mouth a single dose of up to 600 mg (R)-amisulpride and a single dose of dummy medicine. They’ll have 3 PSGs during the study: one before dosing to check their normal quality of sleep, and 1 after each dose. They’ll take up to 5 weeks to finish the study, and have 3 outpatient visits and stay on the ward for 3 nights in total (1 night on 1 occasion and 2 nights on another). \n \nA pharmaceutical company called Sunovion Pharmaceuticals Inc is funding the study. \n\nThe study will take place at 1 research centre in London. \n
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1266
Date of REC Opinion
8 Aug 2016
REC opinion
Favourable Opinion