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

Evotec Neurosciences GmbH1 site in 1 country19 target enrollmentSeptember 2007

ConditionsHuman Volunteers

InterventionsEVT 101 placebo

DrugsEVT 101 placebo

Overview

Phase: Phase 1
Intervention: EVT 101
Conditions: Human Volunteers
Sponsor: Evotec Neurosciences GmbH
Enrollment: 19
Locations: 1
Primary Endpoint: Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

December 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Evotec Neurosciences GmbH

Eligibility Criteria

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