NCT00526968CompletedPhase 1
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
Evotec Neurosciences GmbH1 site in 1 country19 target enrollmentStarted: September 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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
Arms & Interventions
1
Experimental
EVT 101 8 mg capsule
Intervention: EVT 101 (Drug)
2
Experimental
EVT 101 15 mg capsule
Intervention: EVT 101 (Drug)
3
Placebo Comparator
Matching placebo capsule
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
Time Frame: 2-hours post dose
Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo
Time Frame: 2-hours post dose
Performance scores in the cognitive tests
Time Frame: 2-hours post dose
Secondary Outcomes
- Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs(Up to 24 hours post dose and 5-7 days post last dose)
Investigators
Study Sites (1)
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