A PET study in healthy volunteers after oral MR1916; version 1
Research type
Research Study
Full title
An Open-Label [11C]-IMA107 Positron Emission Tomography Study to Determine Phosphodiesterase10A Occupancy by MR1916 after a Single Oral Dose in Healthy Volunteers (16-001)
IRAS ID
206988
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Mochida Pharmaceutical Co, Ltd
Eudract number
2016-000876-64
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
MR1916 (the study medicine) is an experimental new medicine for treating 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 (PDE10A). We hope that the study medicine will work better, and have fewer side effects, than existing medicines. \n\nWe’re doing this study in up to 10 healthy men, aged 25–55, to find out how much of the study medicine gets into the brain and attaches (‘binds’) to PDE10A. To find out, we’ll do PET (positron emission tomography) scans, which make images of the brain. We’ll also assess blood levels of the study medicine and whether it has any important side effects. \n\nParticipants will take a single dose of up to 15 mg study medicine, by mouth, and have up to 4 PET scans and 1 MRI (magnetic resonance imaging) scan. They’ll take up to about 14 weeks to finish the study. They’ll have 2 screening visits, 2 study sessions and 1 follow-up visit, and we’ll telephone them 1–2 weeks after their last visit. They’ll stay on the ward for 1 night in the first study session and 3 nights in the second. \n\nBefore each PET scan, we’ll give participants an injection of radioactive tracer containing carbon-11; the tracer binds to PDE10A in the brain, and the PET scan shows where the tracer is. Participants will be exposed to radiation similar to 3.5 years’ background radiation. \n\nA pharmaceutical company (Mochida Pharmaceutical Co Ltd) 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 A
REC reference
16/NI/0131
Date of REC Opinion
28 Jul 2016
REC opinion
Favourable Opinion