Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01531920
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2012-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'C551441', 'term': 'perampanel'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-10', 'studyFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2012-02-10', 'lastUpdatePostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone', 'timeFrame': 'baseline to Part A Day 1'}, {'measure': 'Part B: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]) due to perampanel and alcohol combined and perampanel alone', 'timeFrame': 'baseline to Part B Day 62'}, {'measure': 'Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone', 'timeFrame': 'baseline to Part B Day 62'}, {'measure': 'Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone', 'timeFrame': 'Part B Day 34'}], 'secondaryOutcomes': [{'measure': 'Part A: Incidence of AEs when perampanel is administered in combination with alcohol', 'timeFrame': 'baseline to Part A Day 29'}, {'measure': 'Part B: Incidence of AEs when perampanel is administered in combination with alcohol', 'timeFrame': 'baseline to Part B Day 62'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Central Nervous System']}, 'descriptionModule': {'briefSummary': 'A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion:\n\n* Healthy male and female subjects\n* Females agreed to use two medically acceptable methods of contraception, unless they were surgically sterile\n* Aged 18-55 yrs, inclusive\n* Achieved a Continuous Tracking Test (CTT )score increase of \\>1.5 pixels from pre-alcohol when dosed with alcohol during the Screening Period (Day minus 8 plus/minus 2 days)\n* Had a current driving license and drove regularly (e.g., more than 1000 miles a year (Part B only)\n\nExclusion:\n\n* Any history of significant alcohol abuse or psychiatric disease, requiring inpatient admission or prolonged treatment with psychotropic medication\n* Unable to follow the instructions for the psychometric testing\n* Intolerant to the driving simulator (Part B only)\n* Unable to adhere to long periods of confinement (subjects who could not follow the instructions of the protocol, including the meals)\n* Use of prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to Screening (unless drug had a long half life \\[i.e., 5 x t 1/2\\>2 weeks\\]) with the exception of paracetamol (up to 4 g/day), which was allowed up to 12 hours prior to dosing\n* Had taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, or Seville orange products)\n* Had taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing"}, 'identificationModule': {'nctId': 'NCT01531920', 'briefTitle': 'A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol', 'orgStudyIdInfo': {'id': 'E2007-E044-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'alcohol + placebo', 'description': 'Part A alcohol + placebo', 'interventionNames': ['Drug: alcohol + placebo']}, {'type': 'OTHER', 'label': 'alcohol + perampanel', 'description': 'Part A : alcohol + perampanel', 'interventionNames': ['Drug: alcohol + perampanel']}, {'type': 'OTHER', 'label': 'perampanel + alcohol', 'description': 'Part B: perampanel + alcohol', 'interventionNames': ['Drug: perampanel + alcohol']}, {'type': 'OTHER', 'label': 'placebo + alcohol', 'description': 'Part B: placebo + alcohol', 'interventionNames': ['Drug: placebo + alcohol']}], 'interventions': [{'name': 'alcohol + placebo', 'type': 'DRUG', 'description': 'Part A alcohol + placebo', 'armGroupLabels': ['alcohol + placebo']}, {'name': 'alcohol + perampanel', 'type': 'DRUG', 'description': 'Part A: alcohol + perampanel', 'armGroupLabels': ['alcohol + perampanel']}, {'name': 'perampanel + alcohol', 'type': 'DRUG', 'description': 'Part B: perampanel + alcohol', 'armGroupLabels': ['perampanel + alcohol']}, {'name': 'placebo + alcohol', 'type': 'DRUG', 'description': 'Part B: placebo + alcohol', 'armGroupLabels': ['placebo + alcohol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guildford', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Daryl Bendel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surrey Clinical Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}