Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-04-15 @ 7:58 PM
Study NCT ID:
NCT00738959
Status:
COMPLETED
Last Update Posted:
2008-10-29
First Post:
2008-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C543642', 'term': "spiro(1-azabicyclo(2.2.2)octane-3,2'(3H)-furo(2,3-b)pyridine)"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-28', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-08-20', 'lastUpdatePostDateStruct': {'date': '2008-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements', 'timeFrame': 'During the whole treatment period'}], 'secondaryOutcomes': [{'measure': 'PK variables', 'timeFrame': 'Several samples during the study days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AZD0328', 'Japanese', 'Caucasian', 'pharmacokinetics', 'safety', 'tolerability'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.\n* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.\n\nExclusion Criteria:\n\n* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.\n* Participation in another study within 12 weeks before the first administration of the investigational product.\n* Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product."}, 'identificationModule': {'nctId': 'NCT00738959', 'briefTitle': 'Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0328 in Healthy Young Japanese and Caucasian Male Volunteers After Oral Single and Multiple Ascending Doses', 'orgStudyIdInfo': {'id': 'D0190C00008'}, 'secondaryIdInfos': [{'id': 'EUdract NO 2008-001723-56'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD0328']}], 'interventions': [{'name': 'AZD0328', 'type': 'DRUG', 'description': 'Oral solution A single dose Day 1 followed by once daily doses on Day 3-7', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Didier Meulien, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Södertälje, Sweden'}, {'name': 'Ulrike Lorch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Richmond Pharmacology Ltd St George's University of London Cranmer Terrace, TootingLondon SW17 ORE UK"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition', 'oldOrganization': 'AstraZeneca R&D, Södertälje, Sweden'}}}}