Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00878618
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2009-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C551586', 'term': 'AZD 0837'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2009-04-08', 'lastUpdatePostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.', 'timeFrame': 'Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the PK of the intermediate metabolite AR-H069927XX', 'timeFrame': 'Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above.'}, {'measure': 'Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events)', 'timeFrame': 'ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1.'}, {'measure': 'Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4', 'timeFrame': 'Once predose on day 1, session 1 and once predose on day 5, session 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subject aged between 18 to 45 years inclusive\n* Body mass index (BMI) between 19 to 30 kg/m2 inclusive\n* Body weight between 50 to 100 kg inclusive\n* Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.\n\nExclusion Criteria:\n\n* Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product\n* Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry\n* History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder\n* Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.'}, 'identificationModule': {'nctId': 'NCT00878618', 'briefTitle': 'Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single-Centre, Open, Randomized, Two-Way Crossover Study to Evaluate the Pharmacokinetics of the Extended-Release Test Formulation of AZD0837 Compared to the Extended-Release AZD0837 Reference Formulation After Repeated Dosing in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D1250C00056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HAB', 'description': 'AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast', 'interventionNames': ['Drug: AZD0837']}, {'type': 'EXPERIMENTAL', 'label': 'HBA', 'description': 'AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast', 'interventionNames': ['Drug: AZD0837']}, {'type': 'EXPERIMENTAL', 'label': 'LAB', 'description': 'AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast', 'interventionNames': ['Drug: AZD0837']}, {'type': 'EXPERIMENTAL', 'label': 'LBA', 'description': 'AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast', 'interventionNames': ['Drug: AZD0837']}], 'interventions': [{'name': 'AZD0837', 'type': 'DRUG', 'description': 'Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days', 'armGroupLabels': ['HAB', 'LAB']}, {'name': 'AZD0837', 'type': 'DRUG', 'description': 'Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days', 'armGroupLabels': ['HBA', 'LBA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Elisabeth Edén Eden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles AB, Uppsala, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Karin Wåhlander, Medical Science Director', 'oldOrganization': 'AstraZeneca R&D Mölndal'}}}}