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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00526968

Enrollment

Registered

2007-09-10

Start date

2007-09-30

Completion date

2007-12-31

Last updated

2008-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Volunteers

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.

Interventions

DRUGEVT 101

8 mg capsule, single oral dose

DRUGplacebo

Placebo capsule, single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026