Viewing Study NCT00581451


Ignite Creation Date: 2025-12-24 @ 11:46 PM
Ignite Modification Date: 2026-03-10 @ 8:48 PM
Study NCT ID: NCT00581451
Status: COMPLETED
Last Update Posted: 2009-07-10
First Post: 2007-12-21
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C509981', 'term': 'bifeprunox'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-08', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Safety and tolerability study in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy male 18-50 years\n* Nonlactating female 18-50 years'}, 'identificationModule': {'nctId': 'NCT00581451', 'briefTitle': 'Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A 3-Part, Randomized, Multiple-Dose, Sequential Design Study of Bifeprunox in Healthy Subjects in Order to Establish a Titration Regimen With an Improved Tolerability Profile', 'orgStudyIdInfo': {'id': '3168A2-1005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'bifeprunox 25 day', 'interventionNames': ['Drug: bifeprunox']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'bifeprunox 14 day', 'interventionNames': ['Drug: bifeprunox']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'bifeprunox 14 day', 'interventionNames': ['Drug: bifeprunox']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'bifeprunox 9 day', 'interventionNames': ['Drug: bifeprunox']}], 'interventions': [{'name': 'bifeprunox', 'type': 'DRUG', 'description': 'oral tablet once daily', 'armGroupLabels': ['A', 'B', 'C', 'D']}]}, 'contactsLocationsModule': {'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'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}