Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT00871767
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2009-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AZD5672 Bioavailability Study in Healthy Male and Female Subjects
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': 'C553747', 'term': 'N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-29', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss', 'timeFrame': 'Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28'}], 'secondaryOutcomes': [{'measure': 'Safety variables (adverse events, blood pressure, pulse, safety lab)', 'timeFrame': 'AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AZD5672', 'relative bioavailability', 'rheumatoid arthritis (RA)'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study-specific procedures\n* BMI between 18 and 30 kg/m2\n* Medical and surgical history and physical examination without any clinically significant findings\n* Non smokers or past smokers who have stopped smoking within the last 6 months.\n\nExclusion Criteria:\n\n* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator\n* Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.\n* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00871767', 'briefTitle': 'AZD5672 Bioavailability Study in Healthy Male and Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'D1710C00019'}, 'secondaryIdInfos': [{'id': 'EudraCt No. 2009-009423-10'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '40 or 100mg AZD5672, Reference formulation', 'interventionNames': ['Drug: AZD5672']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '40 or 100mg AZD5672, Test formulation', 'interventionNames': ['Drug: AZD5672']}], 'interventions': [{'name': 'AZD5672', 'type': 'DRUG', 'description': '40 mg tablet (Test formulation)', 'armGroupLabels': ['2']}, {'name': 'AZD5672', 'type': 'DRUG', 'description': '40 mg tablet (Reference formulation)', 'armGroupLabels': ['1']}, {'name': 'AZD5672', 'type': 'DRUG', 'description': '100 mg tablet (Test formulation)', 'armGroupLabels': ['2']}, {'name': 'AZD5672', 'type': 'DRUG', 'description': '100 mg (2 x 50 mg tablet (Reference Formulation)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Mark Layton', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca R&D, Alderley Park, UK'}, {'name': 'Simon Constable', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICON Development Solutions, Manchester, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Layton, MD, PhD, Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}