Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-06 @ 9:56 AM
Study NCT ID:
NCT01184092
Status:
COMPLETED
Last Update Posted:
2010-10-14
First Post:
2010-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-12', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550).', 'timeFrame': 'PK blood samples out to 24 hours post dose in each period'}], 'secondaryOutcomes': [{'measure': 'PK parameters: Tmax, t½ of tasocitinib (CP-690,550).', 'timeFrame': 'Derived from PK blood samples out to 24 hours post dose in each period.'}, {'measure': 'Safety: laboratory tests.', 'timeFrame': 'Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3.'}, {'measure': 'Safety: vital signs', 'timeFrame': 'Prior to dosing in each period and at 24 hours post last dose in Period 3.'}, {'measure': 'Safety: adverse event reporting', 'timeFrame': 'Throughout study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'healthy volunteer study', 'Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921075&StudyName=A%20Study%20To%20Compare%20The%20Amount%20Of%20Tasocitinib%20%28CP-690%2C550%29%20That%20Is%20Absorbed%20Into%20The%20Blood%20Of%20Healthy%20Subjects%20Following%20Oral%20Adm', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.', 'detailedDescription': 'This is a pivotal bioequivalence study for tasocitinib (CP-690,550).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males\\>50 kg (110 lbs). For females, total body weight \\>45 kg (99 lbs).\n* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).\n\nExclusion Criteria:\n\n* Evidence of any clinically significant illness, medical condition, or disease.\n* Evidence or history of any clinically significant infections within the past 3 months.\n* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.'}, 'identificationModule': {'nctId': 'NCT01184092', 'briefTitle': 'A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions', 'orgStudyIdInfo': {'id': 'A3921075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment C', 'Drug: Treatment B']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'interventionNames': ['Drug: Treatment B', 'Drug: Treatment C', 'Drug: Treatment A']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'interventionNames': ['Drug: Treatment B', 'Drug: Treatment A', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'interventionNames': ['Drug: Treatment C', 'Drug: Treatment A', 'Drug: Treatment B']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'interventionNames': ['Drug: Treatment C', 'Drug: Treatment B', 'Drug: Treatment A']}], 'interventions': [{'name': 'Treatment A', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).', 'armGroupLabels': ['Sequence 1']}, {'name': 'Treatment B', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).', 'armGroupLabels': ['Sequence 1']}, {'name': 'Treatment C', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).', 'armGroupLabels': ['Sequence 1']}, {'name': 'Treatment A', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).', 'armGroupLabels': ['Sequence 2']}, {'name': 'Treatment C', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).', 'armGroupLabels': ['Sequence 2']}, {'name': 'Treatment B', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).', 'armGroupLabels': ['Sequence 2']}, {'name': 'Treatment B', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).', 'armGroupLabels': ['Sequence 3']}, {'name': 'Treatment C', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).', 'armGroupLabels': ['Sequence 3']}, {'name': 'Treatment A', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).', 'armGroupLabels': ['Sequence 3']}, {'name': 'Treatment B', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).', 'armGroupLabels': ['Sequence 4']}, {'name': 'Treatment A', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).', 'armGroupLabels': ['Sequence 4']}, {'name': 'Treatment C', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).', 'armGroupLabels': ['Sequence 4']}, {'name': 'Treatment C', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).', 'armGroupLabels': ['Sequence 5']}, {'name': 'Treatment A', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).', 'armGroupLabels': ['Sequence 5']}, {'name': 'Treatment B', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).', 'armGroupLabels': ['Sequence 5']}, {'name': 'Treatment C', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).', 'armGroupLabels': ['Sequence 6']}, {'name': 'Treatment B', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).', 'armGroupLabels': ['Sequence 6']}, {'name': 'Treatment A', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).', 'armGroupLabels': ['Sequence 6']}]}, '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': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}