Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT01143805
Status:
COMPLETED
Last Update Posted:
2010-08-10
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D007262', 'term': 'Infusions, Intravenous'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D061605', 'term': 'Administration, Intravenous'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007263', 'term': 'Infusions, Parenteral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-06', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf of tasocitinib (CP 690,550)', 'timeFrame': 'PK blood samples out to 12 hours post dose'}], 'secondaryOutcomes': [{'measure': 'AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).', 'timeFrame': 'PK blood samples out to 12 hours postdose'}, {'measure': 'Safety Laboratory tests: hematology, chemistry, urine testing', 'timeFrame': 'Safety Laboratory testing performed out to 2 days post last dose'}, {'measure': 'Vital Signs: Blood pressure, heart rate, oral temperature', 'timeFrame': 'Vital signs out to 2 days post last dose'}, {'measure': 'AE Reporting', 'timeFrame': 'Throughout study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Absolute Bioavailability', 'Rheumatoid Arthritis'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921077&StudyName=A%20Study%20To%20Estimate%20The%20Amount%20Of%20CP-690%2C550%20%28Study%20Drug%29%20That%20Is%20Absorbed%20Into%20The%20Blood%20Of%20Healthy%20Subjects%20Following%20Oral%20A', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.', 'detailedDescription': 'To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.'}, '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)\n* 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 \\>50 kg (110 lbs)\n* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)\n\nExclusion Criteria:\n\n* Evidence or history of any clinically significant illness, medical condition, or disease.\n\n 2\\. Evidence or history of any clinically significant infections within the past 3 months.\n\n 3\\. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.'}, 'identificationModule': {'nctId': 'NCT01143805', 'briefTitle': 'A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A3921077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: Tasocitinib 10 mg oral tablet', 'interventionNames': ['Drug: Tasocitinib 10 mg oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Tasocitinib 10 mg IV Infusion', 'interventionNames': ['Drug: Tasocitinib 10 mg IV Infusion']}], 'interventions': [{'name': 'Tasocitinib 10 mg oral tablet', 'type': 'DRUG', 'description': 'Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet', 'armGroupLabels': ['Treatment A: Tasocitinib 10 mg oral tablet']}, {'name': 'Tasocitinib 10 mg IV Infusion', 'type': 'DRUG', 'description': 'Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion', 'armGroupLabels': ['Treatment B: Tasocitinib 10 mg IV Infusion']}]}, '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.'}}}}