Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT00526968
Status:
COMPLETED
Last Update Posted:
2008-02-18
First Post:
2007-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-14', 'studyFirstSubmitDate': '2007-09-07', 'studyFirstSubmitQcDate': '2007-09-07', 'lastUpdatePostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks', 'timeFrame': '2-hours post dose'}, {'measure': 'Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo', 'timeFrame': '2-hours post dose'}, {'measure': 'Performance scores in the cognitive tests', 'timeFrame': '2-hours post dose'}], 'secondaryOutcomes': [{'measure': 'Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs', 'timeFrame': 'Up to 24 hours post dose and 5-7 days post last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Human Volunteers']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Male volunteers\n* Body Mass Index between 19 and 29\n\nExclusion Criteria:\n\n* Subjects who received any prescribed medication within 5 half lives or 14 days of the first dose administration whichever is the longer\n* 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\n* Participation in a clinical trial of an investigational drug within the past 4 months or of a marketed drug within the past 3 months\n* History of allergy to NMDA antagonists or other clinically significant drug allergy\n* 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\n* Consumption of more than 21 units of alcohol per week or history of alcoholism or drug/chemical abuse\n* Smokers of more than 5 cigarettes or equivalent per day\n* Subjects who cannot complete the neuropsychological test battery\n* Any clinically significant health deficit'}, 'identificationModule': {'nctId': 'NCT00526968', 'briefTitle': 'The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evotec International GmbH'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EVT 101/1002'}, 'secondaryIdInfos': [{'id': 'EudraCT No.: 2007-000986-40'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'EVT 101 8 mg capsule', 'interventionNames': ['Drug: EVT 101']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'EVT 101 15 mg capsule', 'interventionNames': ['Drug: EVT 101']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Matching placebo capsule', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'EVT 101', 'type': 'DRUG', 'description': '8 mg capsule, single oral dose', 'armGroupLabels': ['1']}, {'name': 'EVT 101', 'type': 'DRUG', 'description': '15 mg capsule, single oral dose', 'armGroupLabels': ['2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo capsule, single oral dose', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 8AF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Centre for Neuroimaging Science, Box 089, Institute of Psychiatry', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nigel Leigh, BSc MBBS Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Neurosciences, Institute of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evotec Neurosciences GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Richmond Pharmacology Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr Hermann Fuder, Senior VP, Clinical Development', 'oldOrganization': 'Evotec Neurosciences GmbH'}}}}