Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-26 @ 10:59 PM
Study NCT ID:
NCT00689403
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2008-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C550721', 'term': 'tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-01', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic variables', 'timeFrame': 'During all dosing visits'}], 'secondaryOutcomes': [{'measure': 'Adverse events, ECG, safety laboratory, vital signs, physical examination', 'timeFrame': 'During the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AZD1305', 'pharmacokinetics', 'Properties of different ER formulations'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male between the age of 20 - 45\n* Non-smoking\n\nExclusion Criteria:\n\n* Potassium outside normal reference values\n* ECG findings outside normal range'}, 'identificationModule': {'nctId': 'NCT00689403', 'acronym': '2007-005765-38', 'briefTitle': 'Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Two-part, Randomised, Open, Single-centre, Crossover Study to Evaluate Different Extended-release Formulations of AZD1305 When Given as Single Oral Doses to Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D3190C00014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: 2x2 crossover', 'description': '4 different AZD1305 ER formulations', 'interventionNames': ['Drug: AZD1305']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 3x3 crossover', 'description': '2 different AZD1305 ER formulations and a reference formulation', 'interventionNames': ['Drug: AZD1305']}], 'interventions': [{'name': 'AZD1305', 'type': 'DRUG', 'description': 'Extended release capsules, oral single doses', 'armGroupLabels': ['Part A: 2x2 crossover']}, {'name': 'AZD1305', 'type': 'DRUG', 'description': 'Extended release capsules, oral single doses', 'armGroupLabels': ['Part B: 3x3 crossover']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Helen Lunde, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Mölndal, Sweden'}, {'name': 'Daniel Bradford, MD, MA, MBBS, DCPSA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids', 'oldOrganization': 'AstraZeneca'}}}}