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

Human Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526968
• Other study ID #: EVT 101/1002
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2007
• Last updated: February 14, 2008
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2008
• Source: Evotec Neurosciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Human Volunteers

Intervention

Drug:
• EVT 101
8 mg capsule, single oral dose
• EVT 101
15 mg capsule, single oral dose
• placebo
Placebo capsule, single oral dose

Locations

Country	Name	City	State
United Kingdom	Centre for Neuroimaging Science, Box 089, Institute of Psychiatry	London

Sponsors (2)

Lead Sponsor	Collaborator
Evotec Neurosciences GmbH	Richmond Pharmacology Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks		2-hours post dose	No
Primary	Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo		2-hours post dose	No
Primary	Performance scores in the cognitive tests		2-hours post dose	No
Secondary	Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs		Up to 24 hours post dose and 5-7 days post last dose	Yes