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

This study has been completed.
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by:
Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:
NCT00526968
First received: September 7, 2007
Last updated: February 14, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Human Volunteers
Drug: EVT 101
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Evotec Neurosciences GmbH:

Primary Outcome Measures:
  • Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks [ Time Frame: 2-hours post dose ] [ Designated as safety issue: No ]
  • Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo [ Time Frame: 2-hours post dose ] [ Designated as safety issue: No ]
  • Performance scores in the cognitive tests [ Time Frame: 2-hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526968

Locations
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
Investigators
Principal Investigator: Nigel Leigh, BSc MBBS Phd Department of Clinical Neurosciences, Institute of Psychiatry
  More Information

No publications provided

Responsible Party: Dr Hermann Fuder, Senior VP, Clinical Development, Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier: NCT00526968     History of Changes
Other Study ID Numbers: EVT 101/1002, EudraCT No.: 2007-000986-40
Study First Received: September 7, 2007
Last Updated: February 14, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 23, 2014