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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2007

Interventions

  • Drug: EVT 101
    • 8 mg capsule, single oral dose
  • Drug: EVT 101
    • 15 mg capsule, single oral dose
  • Drug: placebo
    • Placebo capsule, single oral dose

Arms, Groups and Cohorts

  • Experimental: 1
    • EVT 101 8 mg capsule
  • Experimental: 2
    • EVT 101 15 mg capsule
  • Placebo Comparator: 3
    • Matching placebo capsule

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Evotec Neurosciences GmbH
  • Collaborator
    • Richmond Pharmacology Limited
  • Provider of Information About this Clinical Study
    • Dr Hermann Fuder, Senior VP, Clinical Development, Evotec Neurosciences GmbH
  • Overall Official(s)
    • Nigel Leigh, BSc MBBS Phd, Principal Investigator, Department of Clinical Neurosciences, Institute of Psychiatry

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