Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F2695 | Experimental | Single dose - 2 capsules / Day on Day 1 and Day 8 |
|
| placebo | Placebo Comparator | Single dose - 2 capsules / Day on Day 1 and Day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F2695 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Motor system cortical areas activation magnitude during a paced motor task. |
| 1 day (Period 1/Day +1, Period 2/Day +8) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) as a measure of safety and tolerability | up to 2 weeks |
Not provided
Inclusion Criteria:
Male right-handed*, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form
Exclusion Criteria:
Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.
History of obstructive voiding symptoms, including urinary retention.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| François Chollet | Hôpital Purpan CHU TOULOUSE, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique (CIC) | Toulouse | France |
Not provided
Not provided
Not provided
Not provided
Not provided
|