Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT01330758
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2011-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C548875', 'term': 'AZD 8931'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-28', 'studyFirstSubmitDate': '2011-03-22', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation.', 'timeFrame': 'Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period'}], 'secondaryOutcomes': [{'measure': 'To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).', 'timeFrame': 'From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'Healthy male and non-fertile female volunteers', 'Bioavailability', 'AZD8931'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A study to compare two different tablet formulations of AZD8931 in healthy males and females.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged 18 to 55 years\n* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential\n* Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg\n* Male subjects must be willing to use barrier methods of contraception\n* Be willing and able to comply with study procedures, restrictions and requirements\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder\n* Any clinically significant abnormalities at screening\n* Use of any prescribed or non-prescribed medication within 2 weeks\n* Receipt of another NCE or participation in any other clinical trial within 3 months\n* Subjects who have previously received AZD8931'}, 'identificationModule': {'nctId': 'NCT01330758', 'briefTitle': 'A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II Wet Granulation Tablet Formulation Compared to the Phase II/III Roller Compacted Tablet Formulation of AZD8931', 'orgStudyIdInfo': {'id': 'D0102C00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '40 mg AZD8931 wet granulation tablet formulation', 'interventionNames': ['Drug: AZD8931']}, {'type': 'EXPERIMENTAL', 'label': '40 mg AZD8931 roller compacted tablet formulation', 'interventionNames': ['Drug: AZD8931']}], 'interventions': [{'name': 'AZD8931', 'type': 'DRUG', 'description': '40 mg AZD8931 wet granulation tablet formulation', 'armGroupLabels': ['40 mg AZD8931 wet granulation tablet formulation']}, {'name': 'AZD8931', 'type': 'DRUG', 'description': '40 mg AZD8931 roller compacted tablet formulation', 'armGroupLabels': ['40 mg AZD8931 roller compacted tablet formulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Mary Stuart', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK'}, {'name': 'Dr Darren Wilbraham, DICP, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Quintiles Drug Research Unit at Guy's Hospital"}, {'name': 'Jason Clark, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': "Quintiles Drug Research Unit at Guy's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mary Stuart/Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}