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Completed

NCT Number: NCT00526968

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

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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Key information

Conditions

Human Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Neuroimaging Science, Box 089, Institute of Psychiatry

London, SE5 8AF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVT 101

Drug

8 mg capsule, single oral dose

Placebo

Drug

Placebo capsule, single oral dose

Primary outcomes

  1. Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks

    Time frame: 2-hours post dose

  2. Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo

    Time frame: 2-hours post dose

  3. Performance scores in the cognitive tests

    Time frame: 2-hours post dose

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Evotec Neurosciences GmbH

Industry

Collaborators

  • Richmond Pharmacology Limited

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 10, 2007
Registry last updated
Feb 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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