Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging

Phase 1

Completed

• Conditions: Subject
• Interventions: Drug: F2695; Drug: Placebo

• Registration Number: NCT02266966
• Lead Sponsor: Pierre Fabre Medicament

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study Start: 2014-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
F2695	F2695	Single dose - 2 capsules / Day on Day 1 and Day 8
placebo	Placebo	Single dose - 2 capsules / Day on Day 1 and Day 8

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) as a measure of safety and tolerability	up to 2 weeks

Trial Locations

Locations (1)

Centre d'Investigation Clinique (CIC); 🇫🇷 Toulouse, France