Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-07 @ 3:26 PM
Study NCT ID:
NCT03399734
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}, {'measure': 'Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h])', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}], 'secondaryOutcomes': [{'measure': 'Time at which the highest drug concentration occurs (tmax)', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}, {'measure': 'Lag time (tlag)', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2', 'description': 'tlag is the time delay between drug administration and the onset of drug absorption.'}, {'measure': 'Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h])', 'timeFrame': '0-72 hours postdose of Treatment Period 1 and Treatment Period 2'}, {'measure': 'Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t])', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}, {'measure': 'Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf])', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}, {'measure': 'Terminal phase rate constant (λz)', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}, {'measure': 'Terminal elimination phase half-life (t1/2)', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': '0-168 hours postdose of Treatment Period 1 and Treatment Period 2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perampanel', 'Bioequivalence', 'fine granules', 'E2007', 'Japanese'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nParticipants must meet all of the following criteria to be included in this study:\n\n* Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.\n* Body Mass Index ≥18.5 and \\<25.0 kilograms per meters squared at Screening\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be excluded from this study:\n\n* Females who are breastfeeding or pregnant at Screening or Baseline\n* Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing\n* Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing\n* Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening\n* Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening\n* A prolonged QT/QT corrected interval (QT interval, Fridericia correction \\>450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline'}, 'identificationModule': {'nctId': 'NCT03399734', 'briefTitle': 'Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': 'E2007-J081-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': '4 milligrams (mg) perampanel tablet', 'interventionNames': ['Drug: Perampanel']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': '4 mg perampanel fine granules', 'interventionNames': ['Drug: Perampanel']}], 'interventions': [{'name': 'Perampanel', 'type': 'DRUG', 'otherNames': ['E2007'], 'description': 'Single oral dose of 1 x 4-mg perampanel tablet', 'armGroupLabels': ['Treatment A']}, {'name': 'Perampanel', 'type': 'DRUG', 'otherNames': ['E2007'], 'description': 'Single 4-mg dose of perampanel fine granules', 'armGroupLabels': ['Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Eisai Trial Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}