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

NCT00526968 | Completed Phase 1

• 2 other identifiers: EVT 101/1002EudraCT No.: 2007-000986-40
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Volunteers

Outcome Measures

Primary Outcomes (3)

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

  2-hours post dose

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

  2-hours post dose

• Performance scores in the cognitive tests

  2-hours post dose

Secondary Outcomes (1)

• Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs

  Up to 24 hours post dose and 5-7 days post last dose

Study Arms (3)

1

EXPERIMENTAL

EVT 101 8 mg capsule

Drug: EVT 101

2

EXPERIMENTAL

EVT 101 15 mg capsule

Drug: EVT 101

3

PLACEBO COMPARATOR

Matching placebo capsule

Drug: placebo

Interventions

EVT 101 DRUG

8 mg capsule, single oral dose

1

placebo DRUG

Placebo capsule, single oral dose

3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Male volunteers
• Body Mass Index between 19 and 29

You may not qualify if:

• 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

Sponsors & Collaborators

• Evotec Neurosciences GmbH: lead
• Richmond Pharmacology Limited: collaborator

Study Sites (1)

Centre for Neuroimaging Science, Box 089, Institute of Psychiatry

London, SE5 8AF, United Kingdom

Location

Study Officials

• Nigel Leigh, BSc MBBS Phd

  Department of Clinical Neurosciences, Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 18, 2008

Record last verified: 2008-02

Locations

GB (1)