Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01251835
Status:
WITHDRAWN
Last Update Posted:
2015-03-05
First Post:
2010-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106276', 'term': 'sitaxsentan'}, {'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2010-12-01', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.', 'timeFrame': '24 hours'}, {'measure': 'Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sitaxsentan', 'Rifampin', 'Drug Interaction', 'Pharmacokinetics'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321060&StudyName=Effect%20Of%20Rifampin%20On%20Pharmacokinetics%20Of%20Sitaxsentan', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects and/or women of non-child bearing potential.\n* Subjects between the ages of 21 and 55 years, inclusive.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.\n* Has hepatic dysfunction.\n* Has history of excessive alcohol and tobacco use.'}, 'identificationModule': {'nctId': 'NCT01251835', 'briefTitle': 'Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B1321060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sitaxsentan', 'interventionNames': ['Drug: Sitaxsentan alone']}, {'type': 'EXPERIMENTAL', 'label': 'Sitaxsentan plus Rifampin', 'interventionNames': ['Drug: Sitaxsentan', 'Drug: Rifampin']}], 'interventions': [{'name': 'Sitaxsentan alone', 'type': 'DRUG', 'description': 'Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)', 'armGroupLabels': ['Sitaxsentan']}, {'name': 'Sitaxsentan', 'type': 'DRUG', 'description': 'Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)', 'armGroupLabels': ['Sitaxsentan plus Rifampin']}, {'name': 'Rifampin', 'type': 'DRUG', 'description': 'Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)', 'armGroupLabels': ['Sitaxsentan plus Rifampin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}