Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-26 @ 5:43 AM
Study NCT ID:
NCT00914303
Status:
COMPLETED
Last Update Posted:
2010-04-06
First Post:
2009-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000602652', 'term': 'AZD3241'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-05', 'studyFirstSubmitDate': '2009-06-01', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2010-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables (adverse events, vital signs, ECG, safety lab)', 'timeFrame': 'Assessments performed at frequent timepoints during a 4-8 week period'}], 'secondaryOutcomes': [{'measure': 'To characterize the pharmacokinetics of AZD3241 in plasma', 'timeFrame': 'Frequent sampling occasions during some study days for a 4-8 weeks period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Safety', 'tolerability', 'healthy', 'Healthy volunteer study'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects 30-65 years\n* Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder\n* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs\n* Previous history of frequent pre-syncope or syncope'}, 'identificationModule': {'nctId': 'NCT00914303', 'briefTitle': 'Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended Release Tablets of AZD3241 After Administration of Multiple Ascending Doses in Healthy Male and Female Volunteers Including Food Effect', 'orgStudyIdInfo': {'id': 'D0490C00002'}, 'secondaryIdInfos': [{'id': 'EudraCT No 2007-003145-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD3241', 'description': 'AZD3241 Tablets', 'interventionNames': ['Drug: AZD3241']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo Tablets', 'interventionNames': ['Drug: Placebo Tablet']}], 'interventions': [{'name': 'AZD3241', 'type': 'DRUG', 'description': 'Oral Tablet, Repeated Administration', 'armGroupLabels': ['AZD3241']}, {'name': 'Placebo Tablet', 'type': 'DRUG', 'description': 'Oral Tablet. Repeated Administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Rolf Karlsten, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Science Director AstraZeneca R&D Södertälje.'}, {'name': 'Wolfgang Kuhn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles AB Phase I Unit, Uppsala, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rolf Karlsten , MD, PhD, Medical Science Director', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}