Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-28 @ 3:57 AM
Study NCT ID:
NCT00707551
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2008-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Interaction Study of Ketoconazole/Verapamil Versus AZD1305
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'D014700', 'term': 'Verapamil'}, {'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'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2008-06-27', 'studyFirstSubmitQcDate': '2008-06-27', 'lastUpdatePostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic variables', 'timeFrame': 'During all dosing visits'}], 'secondaryOutcomes': [{'measure': 'Adverse events, vital signs, ECG, laboratory variables and physical examination', 'timeFrame': 'During the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AZD1305', 'Verapamil', 'Ketoconazole', 'pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2\n\nExclusion Criteria:\n\n* Potassium outside normal reference values\n* ECG findings outside normal range'}, 'identificationModule': {'nctId': 'NCT00707551', 'briefTitle': 'An Interaction Study of Ketoconazole/Verapamil Versus AZD1305', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D3190C00009'}, 'secondaryIdInfos': [{'id': '2008-000578-18 (EudraCT No)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Ketoconazole tablet + AZD1305 Extended Release tablet', 'interventionNames': ['Drug: Ketoconazole', 'Drug: AZD1305']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Verapamil Extended Release tablet + AZD1305 Extended Release tablet', 'interventionNames': ['Drug: Verapamil', 'Drug: AZD1305']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'AZD1305 Extended Release tablet', 'interventionNames': ['Drug: AZD1305']}], 'interventions': [{'name': 'Ketoconazole', 'type': 'DRUG', 'otherNames': ['Fungoral'], 'description': 'Tablet, administered as repeated doses.', 'armGroupLabels': ['1']}, {'name': 'Verapamil', 'type': 'DRUG', 'otherNames': ['Isoptin Retard'], 'description': 'Extended Release tablet, administered as repeated doses.', 'armGroupLabels': ['2']}, {'name': 'AZD1305', 'type': 'DRUG', 'description': 'Extended Release tablet, administered as a single dose.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Helen Lunde, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Mölndal, Sweden'}, {'name': 'Dago Mazur, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PAREXEL International GmbH, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}