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

• Sponsor: Evotec Neurosciences GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00526968
• Collaborator: Richmond Pharmacology Limited (Industry)
• Enrollment: 19
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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: EVT 101; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• 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: Sep 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks [2-hours post dose]

2. Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo [2-hours post dose]

3. Performance scores in the cognitive tests [2-hours post dose]

Secondary Outcome Measures

1. Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs [Up to 24 hours post dose and 5-7 days post last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00526968
• Other Study ID Numbers: EVT 101/1002; EudraCT No.: 2007-000986-40
• First Posted: Sep 10, 2007
• Last Update Posted: Feb 18, 2008
• Last Verified: Feb 1, 2008

Study Results

No Results Posted as of Feb 18, 2008