Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00838058
Status:
COMPLETED
Last Update Posted:
2009-10-14
First Post:
2009-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
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': 'C562356', 'term': 'CE 224,535'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-10', 'studyFirstSubmitDate': '2009-02-02', 'studyFirstSubmitQcDate': '2009-02-05', 'lastUpdatePostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2', 'timeFrame': '48 hrs'}], 'secondaryOutcomes': [{'measure': 'safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing', 'timeFrame': '48 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacology formulation normal healthy volunteers food effect'], 'conditions': ['Rheumatoid Arthritis', 'Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6341012&StudyName=A%20study%20in%20normal%20healthy%20people%2C%20testing%20different%20versions%20of%20a%20pill%20that%20will%20be%20used%20to%20treat%20rheumatoid%20arthritis.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-55 and healthy\n\nExclusion Criteria:\n\n* severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse\n* pregnant or wanting to become pregnant'}, 'identificationModule': {'nctId': 'NCT00838058', 'briefTitle': 'A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A6341012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part1; controlled release formulation 4; 250 mg', 'description': 'one 250 mg controlled release tablet, once in the morning, in fasted state', 'interventionNames': ['Drug: CE-224,535']}, {'type': 'EXPERIMENTAL', 'label': 'Part1; controlled release formulation 4; 500 mg', 'description': '2x250 mg, once in the morning, in fasted state', 'interventionNames': ['Drug: CE-224,535']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1; controlled release formula 4; 1000 mg', 'description': '4x250 mg tabs, once in the morning, in fasted state', 'interventionNames': ['Drug: CE-224,535']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1; controlled release formulation 4; 500 mg FED', 'description': '2x250 mg, once in the morning , in fed state', 'interventionNames': ['Drug: CE-224,535']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2; IR formulation 500mg', 'description': '4x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1', 'interventionNames': ['Drug: CE-224,535']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2; IR formulation, 500 mg FED', 'description': '4x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1.', 'interventionNames': ['Drug: CE-224,535']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2; controlled release formulation 5;500 mg, FASTED', 'description': '2x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1.', 'interventionNames': ['Drug: CE 224,535']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2; controlled release formulation 5;500 mg, FED', 'description': '2x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1', 'interventionNames': ['Drug: CE 224,535']}], 'interventions': [{'name': 'CE-224,535', 'type': 'DRUG', 'otherNames': ['Part 1;Treatment A'], 'description': 'one 250mg tablet, once in the morning in fasted state', 'armGroupLabels': ['Part1; controlled release formulation 4; 250 mg']}, {'name': 'CE-224,535', 'type': 'DRUG', 'otherNames': ['Part 1;Treatment B'], 'description': '2x250 mg tablets, once in the morning, in fasted state', 'armGroupLabels': ['Part1; controlled release formulation 4; 500 mg']}, {'name': 'CE-224,535', 'type': 'DRUG', 'otherNames': ['Part 1;Treatment C'], 'description': '4x250mg tablets, once in the morning, in fasted state', 'armGroupLabels': ['Part 1; controlled release formula 4; 1000 mg']}, {'name': 'CE-224,535', 'type': 'DRUG', 'otherNames': ['Part 1;Treatment D'], 'description': '2x250mg tab, once in the morning, after being fed a high fat meal', 'armGroupLabels': ['Part 1; controlled release formulation 4; 500 mg FED']}, {'name': 'CE-224,535', 'type': 'DRUG', 'otherNames': ['Part 2;Treatment E'], 'description': '4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1.', 'armGroupLabels': ['Part 2; IR formulation 500mg']}, {'name': 'CE-224,535', 'type': 'DRUG', 'otherNames': ['Part 2; Treatment F'], 'description': '4x125 mg IR once in the morning after being fed a high fat meal', 'armGroupLabels': ['Part 2; IR formulation, 500 mg FED']}, {'name': 'CE 224,535', 'type': 'DRUG', 'otherNames': ['Part 2; Treatment G'], 'description': '2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state', 'armGroupLabels': ['Part 2; controlled release formulation 5;500 mg, FASTED']}, {'name': 'CE 224,535', 'type': 'DRUG', 'otherNames': ['Part 2; Treatment H'], 'description': '2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal', 'armGroupLabels': ['Part 2; controlled release formulation 5;500 mg, FED']}]}, '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.'}}}}