Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 9:28 AM
Study NCT ID:
NCT00902460
Status:
COMPLETED
Last Update Posted:
2009-08-13
First Post:
2009-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CP-690,550 and Midazolam Drug-Drug Interaction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'C479163', 'term': 'tofacitinib'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-12', 'studyFirstSubmitDate': '2009-05-14', 'studyFirstSubmitQcDate': '2009-05-14', 'lastUpdatePostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf of midazolam', 'timeFrame': '10 Days'}], 'secondaryOutcomes': [{'measure': 'AUClast, Cmax, Tmax, t1/2 of midazolam', 'timeFrame': '10 Days'}, {'measure': 'Vital signs, laboratory tests and adverse events', 'timeFrame': '10 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug interactions CYP3A4 CYP3A5 midazolam anti-rheumatic agents'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921059&StudyName=CP-690%2C550%20and%20Midazolam%20Drug-Drug%20Interaction%20Study', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female (non-child bearing potential) subjects\n\nExclusion Criteria:\n\n* Clinically significant infections within the past 3 months\n* History of previously untreated infection with Mycobacterium tuberculosis\n* Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus'}, 'identificationModule': {'nctId': 'NCT00902460', 'briefTitle': 'CP-690,550 and Midazolam Drug-Drug Interaction Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A3921059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence 1', 'interventionNames': ['Drug: midazolam; CP-690,550 + midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence 2', 'interventionNames': ['Drug: CP-690,550 + midazolam; midazolam']}], 'interventions': [{'name': 'midazolam; CP-690,550 + midazolam', 'type': 'DRUG', 'description': 'Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID', 'armGroupLabels': ['Treatment Sequence 1']}, {'name': 'CP-690,550 + midazolam; midazolam', 'type': 'DRUG', 'description': 'Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone', 'armGroupLabels': ['Treatment Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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.'}}}}