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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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F2695

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

Group Type EXPERIMENTAL

F2695

Intervention Type DRUG

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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F2695

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes