The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to investigate the neurophysiological changes following single doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male subjects.

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Detailed Description

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Conditions

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Human Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

EVT 101 8 mg capsule

Group Type EXPERIMENTAL

EVT 101

Intervention Type DRUG

8 mg capsule, single oral dose

2

EVT 101 15 mg capsule

Group Type EXPERIMENTAL

EVT 101

Intervention Type DRUG

15 mg capsule, single oral dose

3

Matching placebo capsule

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo capsule, single oral dose

Interventions

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EVT 101

8 mg capsule, single oral dose

Intervention Type DRUG

EVT 101

15 mg capsule, single oral dose

Intervention Type DRUG

placebo

Placebo capsule, single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Male volunteers
* Body Mass Index between 19 and 29

Exclusion Criteria

* Subjects who received any prescribed medication within 5 half lives or 14 days of the first dose administration whichever is the longer
* Subjects who have received any prescribed CNS medication or any medication known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
* Participation in a clinical trial of an investigational drug within the past 4 months or of a marketed drug within the past 3 months
* History of allergy to NMDA antagonists or other clinically significant drug allergy
* Supine blood pressure and heart rate of higher than 140/90 mmHg and 90 bpm respectively or lower than 80/40 mmHg and 40 bpm
* Consumption of more than 21 units of alcohol per week or history of alcoholism or drug/chemical abuse
* Smokers of more than 5 cigarettes or equivalent per day
* Subjects who cannot complete the neuropsychological test battery
* Any clinically significant health deficit

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes