Basmisanil Positron Emission Tomography Study in Japanese Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Basmisanil

Study type

Interventional

Funder types

Industry

Identifiers

NCT02534207

2015-001621-16 (EudraCT Number)

BP29784

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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