Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-28 @ 11:38 PM
Study NCT ID:
NCT00689559
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2008-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C490152', 'term': 'ispronicline'}, {'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-30', 'studyFirstSubmitDate': '2008-05-29', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK variables', 'timeFrame': 'Frequent sampling occasions during'}], 'secondaryOutcomes': [{'measure': 'Safety variables (adverse events, blood pressure, pulse, safety lab)', 'timeFrame': 'During the whole treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'AZD3480', 'Aripiprazole'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed written informed consent\n* Clinically normal physical findings and laboratory values\n\nExclusion Criteria:\n\n* Clinically significant illness or clinically relevant trauma within three weeks before the first dose\n* History of clinically significant disease\n* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product'}, 'identificationModule': {'nctId': 'NCT00689559', 'briefTitle': 'Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Single-Centre, Double-Blind, Randomised, Parallel Group Study of Repeated Oral Doses of AZD3480/Placebo and a Single Dose of Aripiprazole to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Aripiprazole in Healthy Subjects (Phase I)', 'orgStudyIdInfo': {'id': 'D3691C00001'}, 'secondaryIdInfos': [{'id': 'EudraCt nr 2008-000310-74'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD3480 + Aripiprazole', 'interventionNames': ['Drug: AZD3480', 'Drug: Aripiprazole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Placebo + Aripiprazole', 'interventionNames': ['Drug: Placebo', 'Drug: Aripiprazole']}], 'interventions': [{'name': 'AZD3480', 'type': 'DRUG', 'description': 'AZD3480 capsules qd, oral, 22 days', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo qd, 12 days', 'armGroupLabels': ['2']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'single dose on day 5', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Lennart Jeppsson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Södertälje, Sweden'}, {'name': 'Ctril Clarke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICON Development Solutions UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hans-Göran Hårdemark, MD, PhD, Medical Science Director', 'oldOrganization': 'AstraZeneca R&D Södertälje'}}}}