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

February 14, 2008 updated by: Evotec Neurosciences GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 8AF
        • Centre for Neuroimaging Science, Box 089, Institute of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
EVT 101 8 mg capsule
Drug: EVT 101
8 mg capsule, single oral dose
Drug: EVT 101
15 mg capsule, single oral dose
Experimental: 2
EVT 101 15 mg capsule
Drug: EVT 101
8 mg capsule, single oral dose
Drug: EVT 101
15 mg capsule, single oral dose
Placebo Comparator: 3
Matching placebo capsule
Drug: placebo
Placebo capsule, single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
Time Frame: 2-hours post dose
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
2-hours post dose
Performance scores in the cognitive tests
Time Frame: 2-hours post dose
2-hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 24 hours post dose and 5-7 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evotec Neurosciences GmbH

Collaborators

Richmond Pharmacology Limited

Investigators

  • Principal Investigator: Nigel Leigh, BSc MBBS Phd, Department of Clinical Neurosciences, Institute of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2008

Last Update Submitted That Met QC Criteria

February 14, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • EVT 101/1002
  • EudraCT No.: 2007-000986-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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