Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:06 PM
Study NCT ID:
NCT00708903
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2008-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487932', 'term': 'neratinib'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-10', 'studyFirstSubmitDate': '2008-06-27', 'studyFirstSubmitQcDate': '2008-07-01', 'lastUpdatePostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QTc interval', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thorough QTc study'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women of nonchildbearing potential,\n* 18-50 years old.\n* Healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.'}, 'identificationModule': {'nctId': 'NCT00708903', 'briefTitle': 'Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Puma Biotechnology, Inc.'}, 'officialTitle': 'A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '3144A1-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'HKI-272', 'interventionNames': ['Drug: neratinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'neratinib', 'type': 'DRUG', 'description': 'HKI-272', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['2']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'armGroupLabels': ['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'}}}}