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

Pierre Fabre

Status and phase: Completed; Phase 1

Conditions: Subject

Treatments: Drug: F2695; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02266966

F02695LP105

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

F2695

Experimental group

Description:

Single dose - 2 capsules / Day on Day 1 and Day 8

Treatment:

Drug: F2695

placebo

Placebo Comparator group

Description:

Single dose - 2 capsules / Day on Day 1 and Day 8

Treatment:

Drug: Placebo