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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526968
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : February 18, 2008
Richmond Pharmacology Limited
Information provided by:
Evotec Neurosciences GmbH

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.

Condition or disease Intervention/treatment Phase
Human Volunteers Drug: EVT 101 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Study Start Date : September 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Experimental: 1
EVT 101 8 mg capsule
Drug: EVT 101
8 mg capsule, single oral dose

Experimental: 2
EVT 101 15 mg capsule
Drug: EVT 101
15 mg capsule, single oral dose

Placebo Comparator: 3
Matching placebo capsule
Drug: placebo
Placebo capsule, single oral dose

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526968

United Kingdom
Centre for Neuroimaging Science, Box 089, Institute of Psychiatry
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
Evotec Neurosciences GmbH
Richmond Pharmacology Limited
Principal Investigator: Nigel Leigh, BSc MBBS Phd Department of Clinical Neurosciences, Institute of Psychiatry

Responsible Party: Dr Hermann Fuder, Senior VP, Clinical Development, Evotec Neurosciences GmbH Identifier: NCT00526968     History of Changes
Other Study ID Numbers: EVT 101/1002
EudraCT No.: 2007-000986-40
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: February 2008