A PET study to assess brain uptake of SEP-4199; version 1
Research type
Research Study
Full title
An Open-label, Single Dose, Positron Emission Tomography Study in Healthy Subjects to Determine Dopamine D2 Receptor Occupancy of Oral Doses of a Fixed 85:15 Ratio of SEP-4199 (85% R-amisulpride:15% S-amisulpride), Using (+)-4-propyl-9-hydroxynaphthoxazine (11C-PHNO)
IRAS ID
225915
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Sunovion Pharmaceuticals Inc
Eudract number
2017-001091-33
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. Schizophrenia and mood disorders are linked to chemical imbalances in the brain. Amisulpride has equal amounts of S-amisulpride and R-amisulpride. The 2 parts of amisulpride 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 16 healthy volunteers (ages 25–45) to find out how much SEP-4199 is needed to treat patients with schizophrenia or mood disorders. We’ll measure how much SEP-4199 binds to sites in the brain, called dopamine receptors, using PET (positron emission tomography) scans, which make images of the brain. We’ll collect blood samples to measure how much SEP-4199 is in the body. We’ll monitor for important side effects.\n\nParticipants will take a single dose of up to 700 milligrams of SEP-4199 (595 milligrams R-amisulpride; 105 milligrams S-amisulpride) by mouth, and have up to 4 PET scans and 1 MRI (magnetic resonance imaging) scan. They’ll take up to 6 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 up to 5 nights in the second.\n\nBefore each PET scan, we’ll give participants an injection of a small amount of tracer containing radioactive carbon-11. The radioactive tracer binds to dopamine receptors in the brain, and the PET scan shows where the tracer is. Participants will be exposed to a radiation amount comparable to approximately 2.5 years of naturally-occurring background radiation.\n\nSunovion 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
HSC REC B
REC reference
17/NI/0059
Date of REC Opinion
21 Apr 2017
REC opinion
Favourable Opinion