Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01336218
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2011-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy 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': 'C523665', 'term': 'fostamatinib'}, {'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-14', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured', 'timeFrame': 'Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured', 'timeFrame': 'Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose'}, {'measure': 'To examine the safety and tolerability of fostamatinib in combination with rifampicin.', 'timeFrame': 'From screening, Day 1 - Day 25, up to follow up visit', 'description': 'Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.'}]}, 'conditionsModule': {'keywords': ['Phase 1', 'healthy volunteers', 'Rheumatoid arthritis', 'RA', 'Fostamatinib', 'Rifampicin', 'drug-drug interaction', 'Pharmacokinetics', 'Amount of Rifampicin in blood'], 'conditions': ['Rheumatoid Arthritis', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects'}, '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* Males or females aged 18 to 55 years (inclusive)\n* Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)\n* Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential\n\nExclusion Criteria:\n\n* History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)\n* Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1\n* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day\n* Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L\n* Any previous treatment with fostamatinib'}, 'identificationModule': {'nctId': 'NCT01336218', 'briefTitle': 'Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin', 'orgStudyIdInfo': {'id': 'D4300C00015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Fostamatinib', 'interventionNames': ['Drug: fostamatinib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Rifampicin', 'interventionNames': ['Drug: fostamatinib', 'Drug: rifampicin']}], 'interventions': [{'name': 'fostamatinib', 'type': 'DRUG', 'description': 'oral tablets, 150mg (3 X 50mg) single dose per period', 'armGroupLabels': ['1', '2']}, {'name': 'rifampicin', 'type': 'DRUG', 'description': 'oral tablets, 600mg (2 X 300mg) 8 doses over 8 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kelli Craven, MD, PI', 'oldOrganization': 'Quintiles, Overland Park, volunteer recruitment'}}}}