Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 3:31 PM
Study NCT ID:
NCT01068756
Status:
TERMINATED
Last Update Posted:
2016-10-17
First Post:
2010-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2010-02-12', 'studyFirstSubmitQcDate': '2010-02-12', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data', 'timeFrame': 'Days 1 to 3 and Days 9 to 11'}], 'secondaryOutcomes': [{'measure': 'Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data', 'timeFrame': 'Days 1 to 3 and Days 9 to 11'}, {'measure': 'Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data', 'timeFrame': 'Days 1 to 3 and Days 9 to 11'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3652&filename=MB102-074_redacted_CSR_synopsis.pdf', 'label': 'MB102-074\\_redacted\\_CSR\\_synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Body Mass Index (BMI) of 18 to 32 inclusive\n* Women who are not of childbearing potential and men, ages 18 to 45\n\nExclusion Criteria:\n\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations\n* Glucosuria\n* Abnormal liver function tests'}, 'identificationModule': {'nctId': 'NCT01068756', 'briefTitle': 'Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MB102-074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dapagliflozin/Rifampin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Rifampin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days', 'armGroupLabels': ['Dapagliflozin/Rifampin']}, {'name': 'Rifampin', 'type': 'DRUG', 'description': 'Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days', 'armGroupLabels': ['Dapagliflozin/Rifampin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ppd Development', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}