Basmisanil Positron Emission Tomography Study in Japanese Volunteers
- Registration Number
- NCT02534207
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the relationship between basmisanil plasma concentrations and the occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5) subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging sessions. In the first imaging session, participants will have a baseline Positron Emission Tomography (PET) scan. In the second imaging session, participants will receive a single oral dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Male or female Japanese healthy volunteer, who was born in Japan, has 4 ethnically Japanese grandparents and has lived outside Japan for no longer than 5 years
- A body mass index (BMI, Quetelet index) in the range 18.0 to 32.0 kilograms per square meter (kg/m^2)
- Willingness and ability to comply with study restrictions
Exclusion Criteria
- A history of epilepsy, convulsions or significant head injury, or other structural brain abnormality
- Pregnant or lactating or not using acceptable contraception
- Presence or history of severe adverse reaction to any drug or a history of sensitivity to basmisanil or the PET radioligand (RO15-4513)
- Significant exposure to radiation within the previous 12 months
- Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Basmisanil in Japanese Healthy Volunteers Basmisanil Japanese healthy volunteers will receive a single oral dose of RO5186582 within 15 minutes after completing a standard meal.
- Primary Outcome Measures
Name Time Method Percentage of Brain α5 Subunit-Containing GABAA Receptors Occupied by Basmisanil (Receptor Occupancy) Following a Single Dose of Basmisanil in Selected Regions of Interest (ROIs) Assessed by PET Imaging Day 1 Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain α5 Subunit-Containing GABAA Receptors Day 1
- Secondary Outcome Measures
Name Time Method Brain GABAA Receptor α5 Subunit Levels in Selected ROIs Assessed by PET Imaging Day 1 Percentage of Participants With Adverse Events From Baseline up to 7-14 days
Trial Locations
- Locations (2)
Hammersmith Medicines Research; Central Middlesex Hospital
🇬🇧London, United Kingdom
Imanova Limited
🇬🇧London, United Kingdom
Hammersmith Medicines Research; Central Middlesex Hospital🇬🇧London, United Kingdom