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

Phase 1

Completed

• Conditions: Human Volunteers
• Interventions: Drug: placebo; Drug: EVT 101

• Registration Number: NCT00526968
• Lead Sponsor: Evotec Neurosciences GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-14
• Last Update Posted: 2008-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	placebo	Matching placebo capsule
1	EVT 101	EVT 101 8 mg capsule
2	EVT 101	EVT 101 15 mg capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs	Up to 24 hours post dose and 5-7 days post last dose

Trial Locations

Locations (1)

Centre for Neuroimaging Science, Box 089, Institute of Psychiatry; 🇬🇧 London, United Kingdom