Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-29 @ 2:46 PM
Study NCT ID:
NCT00908934
Status:
COMPLETED
Last Update Posted:
2009-07-23
First Post:
2009-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD9056 Relative Bioavailability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-22', 'studyFirstSubmitDate': '2009-05-22', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative bioavailability of AZD9056 using PK variables Cmax and AUC', 'timeFrame': 'For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7'}], 'secondaryOutcomes': [{'measure': 'Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)', 'timeFrame': 'For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7'}, {'measure': 'Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)', 'timeFrame': 'Frequent sampling occasions throughout the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relative Bioavailability', 'AZD9056'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 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* Healthy Volunteers, Females should not be of childbearing potential\n* BMI between 18 and 30 kg/m2\n\nExclusion Criteria:\n\n* Clinically significant ECG abnormality suggestive of underlying cardiovascular disease\n* A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs\n* Known or suspected drug or alcohol abuse or positive DOA test'}, 'identificationModule': {'nctId': 'NCT00908934', 'briefTitle': 'AZD9056 Relative Bioavailability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label, Randomized, 2 Cohort, 2 Period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'D1520C00004'}, 'secondaryIdInfos': [{'id': 'EudraCT Number: 2009-010554-35'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '50 or 400 mg AZD9056, Test formulation', 'interventionNames': ['Drug: AZD9056 formulation Phase III 50 mg (T)', 'Drug: AZD9056 formulation Phase III 200 mg (T)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '50 or 400 mg AZD9056, Reference formulation', 'interventionNames': ['Drug: AZD9056 formulation Phase IIb 50 mg (R)', 'Drug: AZD9056 formulation Phase IIb 200mg (R)']}], 'interventions': [{'name': 'AZD9056 formulation Phase III 50 mg (T)', 'type': 'DRUG', 'description': 'Given as 50 mg tablet (T)', 'armGroupLabels': ['1']}, {'name': 'AZD9056 formulation Phase IIb 50 mg (R)', 'type': 'DRUG', 'description': 'Given as 50 mg tablet (R)', 'armGroupLabels': ['2']}, {'name': 'AZD9056 formulation Phase III 200 mg (T)', 'type': 'DRUG', 'description': 'Given as 400 mg (2 x 200 mg tablet (T))', 'armGroupLabels': ['1']}, {'name': 'AZD9056 formulation Phase IIb 200mg (R)', 'type': 'DRUG', 'description': 'Given as 400 mg (2 x 200 mg tablet (R))', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Mark Layton', 'role': 'STUDY_DIRECTOR', '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'}}}}