PET study to assess the distribution of RO7308480 in the brain
Research type
Research Study
Full title
A phase I non-randomized, open label, adaptive, parallel group, human positron emission tomography (PET) study to assess the occupancy of brain γ1 and γ2 containing GABAA receptors of RO7308480 using [11C]RO7285378 and [11C]flumazenil following single oral doses in healthy participants.
IRAS ID
1006931
Contact name
Head, EU/International Regulatory Affairs, Pharmaceuticals Division, PDR
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2022-002358-12
ISRCTN Number
ISRCTN71330683
Research summary
The study medicine (RO7308480) is an experimental medicine for treating social anxiety disorder. People with social anxiety disorder have intense fear or discomfort in social situations. This can lead to difficulties in relationships, work or school life. Current treatments for social anxiety disorder don’t work well for all patients, or have troublesome side effects.
Studies in animals have shown that by activating sites in the brain called GABAA receptors, animals had a decrease in anxiety-like behaviours. We hope RO7308480 will reduce the symptoms of social anxiety disorder by attaching to these sites.
We’ll test single doses of RO7308480 in healthy volunteers to find out its blood levels, side effects, and to measure how much RO7308480 binds to GABAA receptors. To find out, we’ll use a brain scan called a PET (positron emission tomography) scan, which makes images of the brain.
The study is in 2 parts. Part 1 will have up to 5 groups of up to 3 participants and Part 2 will have up to 3 groups of up to 3 participants. Participants will have 2 study sessions. Eligible participants (up to 24 healthy men and women, aged 23–55 years) will take a single dose of RO7308480 by mouth. Participants will have 3 PET scans, and an MRI (magnetic resonance imaging) scan at a separate screening visit. The MRI uses a strong magnetic field to take pictures of the brain.
Participants will take up to 7 weeks to finish the study. They’ll make 3 outpatient visits, and have 2 study sessions. They’ll stay on the ward for 1 night in Session 1, and for 3 nights in Session 2.
A pharmaceutical company (F. Hoffmann-La Roche Ltd) is funding the study.
The study will take place at 1 research centre and 1 imaging centre in London.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0876
Date of REC Opinion
7 Feb 2023
REC opinion
Further Information Favourable Opinion