A PET study to assess brain uptake of Drug RO7017773; v1
Research type
Research Study
Full title
A Non-Randomized Open Label, Adaptive, Parallel Group, Human Positron Emission Tomography (PET) Study to Assess Occupancy of Brain α5-Containing GABA(A) Receptors of RO7017773 using [11C] Ro15-4513 Following Single Oral Doses in Healthy Participants (17-018).
IRAS ID
241068
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
Roche Pharma Research & Early Development
Eudract number
2017-004400-22
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
RO7017773 (the study medicine) is an experimental new medicine for Autism spectrum disorder (ASD). ASD is a range of developmental conditions that affect the way that people think, feel and behave.
We’re doing this study in up to 15 healthy volunteers, aged 23–55 to measure how much RO7017773 gets into the brain and attaches (‘binds’) to sites in the brain called GABA(A) α5 receptors. We hope that RO7017773 will work by targeting the GABA(A) α5 receptors so that their function returns to normal, and help the symptoms of ASD. We’ll also measure the blood levels of RO7017773 and monitor participants for important side effects.
Participants will attend up to 2 screening visits before the study, during which they’ll have an MRI (magnetic resonance imaging scan). Eligible participants will then have 2 study sessions. In the first session, they'll have 1 PET (positron emission tomography) scan; in the second session, they’ll take a dose of up to 1500 mg RO7017773 and have 2 PET scans after their dose.
Before each PET scan, we’ll give participants an injection of a radioactive tracer containing carbon 11; the PET scan shows where the tracer is in the brain, so we can tell where the receptor is and how much RO7017773 is binding it. Each participant will be exposed to radiation comparable to 2 years’ background radiation.
Participants will take up to 8 weeks to finish the study. They’ll make up to 3 outpatient visits, and stay on the ward for 1 night and 1 day in session 1 and for 3 nights and 4 days in session 2 (4 nights and 5 days in total).
A pharmaceutical company, F. Hoffmann-La Roche Ltd (Roche), is funding the study.
The study will take place at a research unit and an imaging centre in London.
REC name
HSC REC A
REC reference
18/NI/0009
Date of REC Opinion
5 Feb 2018
REC opinion
Favourable Opinion