Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT01253434
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E2022 Patch Formulation Single Dose Phase I Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.', 'timeFrame': '15 days'}]}, 'conditionsModule': {'keywords': ['Transdermal Administration'], 'conditions': ['Japanese Healthy Male Adult Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.', 'detailedDescription': 'This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) ÷ {height(m)× height(m)}\n2. Subjects who are between 20 and 55 years of age at the time of obtaining written consent.\n3. Subjects who are willing to and can comply with the conditions described in the study protocol.\n\nExclusion Criteria\n\n1. Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.\n2. Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration.\n3. Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.\n4. Subjects who have excessive skin hair around the region to put the patch on.\n5. Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.'}, 'identificationModule': {'nctId': 'NCT01253434', 'briefTitle': 'E2022 Patch Formulation Single Dose Phase I Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'E2022 Patch Formulation Single Dose Phase I Study', 'orgStudyIdInfo': {'id': 'E2022-J081-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: E2022']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: E2022']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: E2022']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: E2022']}, {'type': 'EXPERIMENTAL', 'label': '5', 'interventionNames': ['Drug: E2022']}], 'interventions': [{'name': 'E2022', 'type': 'DRUG', 'description': 'E2022 Type A patch', 'armGroupLabels': ['1']}, {'name': 'E2022', 'type': 'DRUG', 'description': 'E2022 Type B patch', 'armGroupLabels': ['2']}, {'name': 'E2022', 'type': 'DRUG', 'description': 'E2022 Type C patch', 'armGroupLabels': ['3']}, {'name': 'E2022', 'type': 'DRUG', 'description': 'E2022 Type D patch', 'armGroupLabels': ['4']}, {'name': 'E2022', 'type': 'DRUG', 'description': 'E2022 Type E patch', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}], 'overallOfficials': [{'name': 'Tomoo Ogawa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}