Centre d'Investigation Clinique (CIC)
Toulouse, France
Completed
NCT Number: NCT02266966
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–40 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
F2695
DrugPlacebo
DrugPrimary outcomes
-
Motor system cortical areas activation magnitude during a paced motor task.
Time frame: 1 day (Period 1/Day +1, Period 2/Day +8)
- Location coordinates (x,y,z),
- Voxel cluster size expressed in terms number of voxels,
- Intensity as measured with a Z-score
Secondary outcomes
-
Incidence of adverse events (AEs) as a measure of safety and tolerability
Time frame: up to 2 weeks
Sponsors and collaborators
Lead sponsor
Pierre Fabre Medicament
Industry
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Oct 17, 2014
- Registry last updated
- Oct 13, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.