Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT00814060
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2008-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C487932', 'term': 'neratinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-10', 'studyFirstSubmitDate': '2008-12-17', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy male and female subjects, ages 18-50.'}, 'identificationModule': {'nctId': 'NCT00814060', 'briefTitle': 'Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Puma Biotechnology, Inc.'}, 'officialTitle': 'A Single Dose Bioavailability Study of 2 New Tablet Formulations of Neratinib Compared With a Reference Capsule in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '3144A1-1117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '40-mg tablet', 'interventionNames': ['Drug: neratinib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '240-mg tablet', 'interventionNames': ['Drug: neratinib']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '80-mg capsule', 'interventionNames': ['Drug: neratinib']}], 'interventions': [{'name': 'neratinib', 'type': 'DRUG', 'description': 'HKI-272', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Puma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biotechnology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puma Biotechnology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}