Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-04 @ 3:17 PM
Study NCT ID:
NCT00316459
Status:
COMPLETED
Last Update Posted:
2007-04-13
First Post:
2006-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008133', 'term': 'Long QT Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C478102', 'term': 'ERB 041'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-11', 'studyFirstSubmitDate': '2006-04-18', 'studyFirstSubmitQcDate': '2006-04-19', 'lastUpdatePostDateStruct': {'date': '2007-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval'}], 'secondaryOutcomes': [{'measure': 'To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.'}]}, 'conditionsModule': {'keywords': ['Healthy', 'Cardiac', 'Pharmacokinetics'], 'conditions': ['Healthy', 'Long QT Syndrome']}, 'descriptionModule': {'briefSummary': 'To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and ECG.\n* Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history.\n\nExclusion Criteria:\n\n* A family history of long QT syndrome and/or cardiac death.\n* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematological, neurological, or psychiatric disease.'}, 'identificationModule': {'nctId': 'NCT00316459', 'briefTitle': 'Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo and Moxifloxacin (Open-Label) Controlled, 4-Period, Crossover Study of the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects', 'orgStudyIdInfo': {'id': '3142A2-110'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ERB-041', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}