Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-25 @ 6:16 PM
Study NCT ID:
NCT00765492
Status:
COMPLETED
Last Update Posted:
2009-06-26
First Post:
2008-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD8529 Multiple Ascending Dose Study in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608263', 'term': 'AZD8529'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-25', 'studyFirstSubmitDate': '2008-10-02', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.', 'timeFrame': 'each visit, at least daily, during the study.'}], 'secondaryOutcomes': [{'measure': 'To characterize the pharmacokinetics of AZD8529 in plasma', 'timeFrame': 'Blood samples will be taken during the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I'], 'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects must be of non-child bearing potential.\n\nExclusion Criteria:\n\n* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod\n* Plasma donation within one month of screening or any blood donation/blood loss \\> 500mL during the 3 months prior to screening\n* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis'}, 'identificationModule': {'nctId': 'NCT00765492', 'briefTitle': 'AZD8529 Multiple Ascending Dose Study in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8529 When Given as Single and Multiple Ascending Oral Doses in Healthy Subjects', 'orgStudyIdInfo': {'id': 'D1960C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD8529']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD8529', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark Smith, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark A. Smith, MD; Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}