Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-31 @ 12:14 PM
Study NCT ID:
NCT00902993
Status:
COMPLETED
Last Update Posted:
2009-10-01
First Post:
2009-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C578484', 'term': '3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-30', 'studyFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2009-05-14', 'lastUpdatePostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers,', 'timeFrame': 'during the whole study period, ca 50 days'}, {'measure': 'Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers.', 'timeFrame': 'during the whole study period, ca 43 days'}], 'secondaryOutcomes': [{'measure': 'Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers.', 'timeFrame': 'PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B'}, {'measure': 'Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers.', 'timeFrame': 'PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MAD', 'NNR', 'to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects', 'AZD1446'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-fertile female, young or elderly Subjects, aged ≥18 to ≤50 or ≥65 to ≤80\n* Body mass index (BMI) between 19 and 30 kg/m2\n* Clinically normal findings on physical examination\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder\n* History of severe allergy/hypersensitivity reactions'}, 'identificationModule': {'nctId': 'NCT00902993', 'briefTitle': 'Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446', '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 AZD1446 in Male and Non-fertile Female, Young and Elderly Healthy Volunteers, After Oral Multiple Ascending Doses', 'orgStudyIdInfo': {'id': 'D1950C00002'}, 'secondaryIdInfos': [{'id': 'EudraCT No. 2008-008389-10'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Part A single and multiple dose and part B fractionated dose', 'interventionNames': ['Drug: AZD1446']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD1446', 'type': 'DRUG', 'description': 'Solution, oral single and multiple dose', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Björn Paulsson, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Marianne Hartford, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca Clinical Pharmacology Unit (CPU) Sahlgrenska University Hospital GöteborgSE-413 45 GöteborgSweden'}, {'name': 'Ingemar Bylesjo, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca Clinical Pharmacology Unit (CPU) C2:84Karolinska University Hospital HuddingeSE-141 86 StockholmSweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'AstraZeneca', 'oldOrganization': 'AstraZeneca'}}}}