Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001621-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basmisanil in Japanese Healthy Volunteers | Experimental | Japanese healthy volunteers will receive a single oral dose of RO5186582 within 15 minutes after completing a standard meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basmisanil | Drug | Single oral dose: Basmisanil doses between 20 milligrams (mg) and 960 mg may be used in this study. The planned doses for the first two participants are 160 mg and 480 mg, respectively. Basmisanil dose for subsequent participants will be decided by the investigator and sponsor during the study, based on on-going review of emerging data. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research; Central Middlesex Hospital | London | NW10 7EW | United Kingdom | |||
Not provided
| ID | Term |
|---|---|
| C000720034 | basmisanil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| London |
| NW10 7EW |
| United Kingdom |
| Imanova Limited | London | W12 0NN | United Kingdom |
| London | W12 0NN | United Kingdom |