Subject
Conditions
Brief summary
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.
Interventions
DRUGF2695
DRUGPlacebo
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor system cortical areas activation magnitude during a paced motor task. | 1 day (Period 1/Day +1, Period 2/Day +8) | 1. Location coordinates (x,y,z), 2. Voxel cluster size expressed in terms number of voxels, 3. Intensity as measured with a Z-score |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) as a measure of safety and tolerability | up to 2 weeks |
Countries
France
Outcome results
None listed