Safety and blood levels of repeated doses of MR1916, version 1
Research type
Research Study
Full title
A randomised, double blind, placebo-controlled, multiple ascending dose study to investigate the safety, tolerability and pharmacokinetics of MR1916 in healthy volunteers (16-006).
IRAS ID
212028
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Mochida Pharmaceutical Co, Ltd
Eudract number
2016-001274-14
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (MR1916) is an experimental new medicine for schizophrenia, a common and serious mental illness. We’re not sure what causes schizophrenia, but it’s been linked to chemical imbalances in the brain. We hope that the study medicine will help correct the chemical imbalance, by targeting a substance in the brain called phosphodiesterase 10A. Current treatments for schizophrenia don’t work very well and can cause unpleasant side effects. We hope that the study medicine will work better, and have fewer side effects than existing medicines.\n\nIn this study, we aim to find out the side effects and blood levels of the study medicine. We’ll give up to 32 healthy men, aged 18–55, once daily doses of the study medicine for 8 days, by mouth. We’ll start with a small dose, and increase the dose as the study progresses.\n\nParticipants will take up to 9 weeks to finish the study. They’ll make 2 outpatient visits and stay on the ward for 13 nights. We’ll telephone participants 1–2 weeks after their last visit to make sure they’re still well.\n\nA pharmaceutical company (Mochida Pharmaceutical) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
16/NI/0148
Date of REC Opinion
16 Aug 2016
REC opinion
Favourable Opinion