Phase 1 PK and PD study of SEP-4199 in healthy subjects (QSC200830)
Research type
Research Study
Full title
An Open-Label Study in Healthy Subjects Evaluating Controlled Release (CR) Formulations of SEP-4199 (a Fixed Ratio of 85% R-amisulpride:15% S-amisulpride) on the Pharmacokinetic and Pharmacodynamic Profiles of Amisulpride Enantiomers
IRAS ID
254624
Contact name
Taryn Corriveau
Contact email
Sponsor organisation
Sunovion Pharmaceuticals Inc.
Eudract number
2018-004030-16
Duration of Study in the UK
0 years, 11 months, 18 days
Research summary
The Sponsor is developing a new test medicine, SEP-4199, for the potential treatment of mood and psychotic disorders, including bipolar disorder. Bipolar disorder, formerly known as manic depression, is a condition that affects your moods, which can swing from one extreme to another. \n\nAmisulpride 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. Both schizophrenia and mood disorders are linked to chemical imbalances in the brain. The 2 parts of amisulpride have different effects on those imbalances. The sponsor are developing a medicine, SEP 4199, based on (S) amisulpride and (R)-amisulpride. It is hoped that the test medicine will improve on current treatments for mood disorders and have fewer side effects than existing treatments. \n \nIn this study, new formulations (recipes) of SEP-4199 are being investigated to potentially treat other mood and psychotic disorders.\n\nThe multi-centre study will consist of up to 3 parts, involving up to 68 healthy males and females.\n\nIn part 1, 18 volunteers will receive multiple tablet formulations as single doses across 5 periods. \n\nIn part 2 (optional), 18 volunteers will receive multiple formulations in either tablet or capsule form as single doses across 6 periods.\n\nIn part 1 and 2 (optional), volunteers will be discharged on Day 3 and there will be a minimum 7-day washout between each period.\n\nIn the imaging arm, 32 volunteers will receive 7 daily doses of the selected formulation from Part 1 or 2, or a reference tablet. Subjects will be discharged on Day 9.\n\nA follow-up visit for safety assessments will occur on Days 8 to 11 (Part 1 and 2)and a washout PET scan will occur on Day 11 or Day 12 (imaging arm only). A PET scan is a type of imaging test that uses radiolabelled tracers to show organ and tissue function.
REC name
HSC REC A
REC reference
18/NI/0208
Date of REC Opinion
3 Dec 2018
REC opinion
Favourable Opinion