Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00861718
Status:
COMPLETED
Last Update Posted:
2009-12-10
First Post:
2009-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-09', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential.', 'timeFrame': 'Safety assessments are made at each visit, at least daily, during the study.'}], 'secondaryOutcomes': [{'measure': 'To characterize the pharmacokinetics of AZD7268 in plasma.', 'timeFrame': 'Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Healthy Volunteer'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Multiple Ascending Dose Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of Informed Consent\n* Healthy male subjects and female subjects (of non-child bearing potential)\n\n * with suitable veins for cannulation or repeated venipuncture\n\nExclusion Criteria:\n\n* Inability to understand or cooperate with given information\n* Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test\n* History of seizure (including infancy febrile seizures) or family history of seizure'}, 'identificationModule': {'nctId': 'NCT00861718', 'briefTitle': 'Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Healthy Subjects', 'orgStudyIdInfo': {'id': 'D1151C00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD7268', 'interventionNames': ['Drug: AZD7268']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD7268', 'type': 'DRUG', 'description': 'Capsule, Oral, QD', 'armGroupLabels': ['AZD7268']}, {'name': 'AZD7268', 'type': 'DRUG', 'description': 'Capsule, Oral, BID', 'armGroupLabels': ['AZD7268']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule, Oral BID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Sylvan Hurewitz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca Clinical Pharmacology Unit, US'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark A. Smith, M.D.', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}