Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01116258
Status:
COMPLETED
Last Update Posted:
2010-10-11
First Post:
2010-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C453362', 'term': 'posizolid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-08', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)', 'timeFrame': 'collected prior to treatment, during treatment, and follow-up for a total of 25 to 52 days(includes upto 28 days for screening)'}], 'secondaryOutcomes': [{'measure': 'characterize the Pharmacokinetics of AZD9742 in blood and urine', 'timeFrame': 'PK-sampling during 14 pre-defined study days for PK profiling'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18-30\n\nExclusion Criteria:\n\n* Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes\n* History of presence of gastrointestinal, hepatic or renal disease'}, 'identificationModule': {'nctId': 'NCT01116258', 'briefTitle': 'A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5847 Following Oral Administration to Healthy Male Subjects and Female Subjects of Non-childbearing Potential', 'orgStudyIdInfo': {'id': 'D3430C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD5847']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD5847', 'type': 'DRUG', 'description': 'oral suspension, 15 days', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral suspension, 15 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Andrew Shaw', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Brendan Smyth', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca'}, {'name': 'David Melnick', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Eleanor Lisbon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MSD', 'oldOrganization': 'AstraZeneca'}}}}