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

Study Overview
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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.

Official Title
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A Double Blind, Placebo Controlled Study to Investigate the Role of NMDA Receptor NR2B Subunit Selective Antagonism on Cognitive Functions and Neurophysiology in Healthy Subjects as Measured With MRI

Conditions
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Human Volunteers

Intervention / Treatment
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* Drug: EVT 101
* Drug: EVT 101
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>EVT 101 8 mg capsule | Drug: EVT 101<br>* 8 mg capsule, single oral dose<br>|
| Experimental: 2<br>EVT 101 15 mg capsule | Drug: EVT 101<br>* 15 mg capsule, single oral dose<br>|
| Placebo Comparator: 3<br>Matching placebo capsule | Drug: placebo<br>* Placebo capsule, single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks |  | 2-hours post dose | 
| Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo |  | 2-hours post dose | 
| Performance scores in the cognitive tests |  | 2-hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs |  | Up to 24 hours post dose and 5-7 days post last dose |