Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-24 @ 7:21 AM
Study NCT ID:
NCT01499004
Status:
COMPLETED
Last Update Posted:
2012-01-12
First Post:
2011-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-11', 'studyFirstSubmitDate': '2011-11-23', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time', 'timeFrame': '72 hours post dose'}, {'measure': 'AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration', 'timeFrame': '72 hours post dose'}, {'measure': 'Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)', 'timeFrame': '72 hours post dose'}, {'measure': 'Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration', 'timeFrame': '72 hours post dose'}, {'measure': 't1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma', 'timeFrame': '72 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation', 'timeFrame': '24 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tofacitinib', 'CP-690', '550', 'relative bioavailability', 'modified release', 'Phase 1'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921131&StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Pharmacokinetics%20And%20Safety%20Of%20Three%20Modified%20Release%20And%20One%20Immediate%20Release%20Formulations%20Of%20Tofaci', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.\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': 'NCT01499004', 'briefTitle': 'A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A3921131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'tofacitinib (CP-690,550) modified-release formulation A-Fed', 'interventionNames': ['Drug: tofacitinib (CP-690,550) modified-release formulation A']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'tofacitinib (CP-690,550) modified-release formulation B1-Fed', 'interventionNames': ['Drug: tofacitinib (CP-690,550) modified-release formulation B1']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'tofacitinib (CP-690,550) modified-release formulation A-Fasted', 'interventionNames': ['Drug: tofacitinib (CP-690,550) modified-release formulation A']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'description': 'tofacitinib (CP-690,550) modified-release formulation B1-Fasted', 'interventionNames': ['Drug: tofacitinib (CP-690,550) modified-release formulation B1']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment E', 'description': 'tofacitinib (CP-690,550) modified-release formulation B2-Fasted', 'interventionNames': ['Drug: tofacitinib (CP-690,550) modified-release formulation B2']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment F', 'description': 'tofacitinib (CP-690,550) immediate-release formulation-Fasted', 'interventionNames': ['Drug: tofacitinib (CP-690,550) immediate-release formulation']}], 'interventions': [{'name': 'tofacitinib (CP-690,550) modified-release formulation A', 'type': 'DRUG', 'description': 'A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.', 'armGroupLabels': ['Treatment A']}, {'name': 'tofacitinib (CP-690,550) modified-release formulation B1', 'type': 'DRUG', 'description': 'A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food', 'armGroupLabels': ['Treatment B']}, {'name': 'tofacitinib (CP-690,550) modified-release formulation A', 'type': 'DRUG', 'description': 'A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food', 'armGroupLabels': ['Treatment C']}, {'name': 'tofacitinib (CP-690,550) modified-release formulation B1', 'type': 'DRUG', 'description': 'A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food', 'armGroupLabels': ['Treatment D']}, {'name': 'tofacitinib (CP-690,550) modified-release formulation B2', 'type': 'DRUG', 'description': 'A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food', 'armGroupLabels': ['Treatment E']}, {'name': 'tofacitinib (CP-690,550) immediate-release formulation', 'type': 'DRUG', 'description': 'A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food', 'armGroupLabels': ['Treatment F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}