Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-25 @ 4:12 AM
Study NCT ID:
NCT02487433
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2015-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2015-06-29', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC inf', 'timeFrame': '48 hours post dose', 'description': 'Area under the plasma concentration-time profile from time zero to infinity (AUCinf).'}, {'measure': 'AUC last', 'timeFrame': '48 hours post dose', 'description': 'Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).'}, {'measure': 'Cmax', 'timeFrame': '48 hours post dose', 'description': 'Maximum observed plasma concentration (Cmax).'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '48 hours post dose'}, {'measure': 'Plasma Decay Half-Life (t 1/2)', 'timeFrame': '48 hours post dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['food effect', 'pharmacokinetics', 'healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;\n* Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;\n* Clinically significant infections within the past 3 months'}, 'identificationModule': {'nctId': 'NCT02487433', 'briefTitle': 'A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, Open Label, Single Dose, 2 Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (mr) 22 Mg Tablets In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A3921217'}, 'secondaryIdInfos': [{'id': '2014-005056-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tofacitinib MR 22 mg Fed', 'description': 'Single dose of tofacitinib MR 22 mg administered under fed conditions', 'interventionNames': ['Drug: Tofacitinib MR 22 mg (Fed)']}, {'type': 'EXPERIMENTAL', 'label': 'Tofacitinib MR 22 mg Fasted', 'description': 'Single dose of tofacitinib MR 22 mg administered under fasted conditions', 'interventionNames': ['Drug: Tofacitinib MR 22 mg (Fasted)']}], 'interventions': [{'name': 'Tofacitinib MR 22 mg (Fed)', 'type': 'DRUG', 'description': 'A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal', 'armGroupLabels': ['Tofacitinib MR 22 mg Fed']}, {'name': 'Tofacitinib MR 22 mg (Fasted)', 'type': 'DRUG', 'description': 'A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours', 'armGroupLabels': ['Tofacitinib MR 22 mg Fasted']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Clinical Research Unit', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}