Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 11:43 AM
Study NCT ID:
NCT00886067
Status:
COMPLETED
Last Update Posted:
2009-09-10
First Post:
2009-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography (PET) Study
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'}, {'id': 'C119803', 'term': '2-fluoro-3-(2-azetidinylmethoxy)pyridine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-09', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.', 'timeFrame': 'One PET assessment on baseline day and one PET assessment at the drug treatment day'}, {'measure': 'Plasma concentration (Cmax, tmax, AUC)', 'timeFrame': 'During time period of the PET assessment'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability (AEs, vital signs, lab)', 'timeFrame': 'During the whole study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AZD1446', 'PET examination'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically healthy volunteers\n* Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder\n* History of severe allergy/hypersensitivity reactions\n* Participation in a PET examination as part of a scientific study during the past twelve months'}, 'identificationModule': {'nctId': 'NCT00886067', 'briefTitle': 'Positron Emission Tomography (PET) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label Positron Emission Tomography (PET) Study Using 2 [18F] F A85380 to Determine α4β2 Neuronal Nicotinic Receptor (NNR) Occupancy of AZD1446 After Oral Administration to Male and Non-fertile Female (Non-nicotine Users) Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D1950C00004'}, 'secondaryIdInfos': [{'id': 'EudraCT No. 2008-008390-55'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2-[18F]-F-A85380', 'description': 'Single microdose', 'interventionNames': ['Radiation: 2-[18F]-F-A85380']}, {'type': 'EXPERIMENTAL', 'label': 'AZD1446', 'description': 'Single oral administration', 'interventionNames': ['Drug: AZD1446']}], 'interventions': [{'name': 'AZD1446', 'type': 'DRUG', 'description': 'Solution, oral, single dose', 'armGroupLabels': ['AZD1446']}, {'name': '2-[18F]-F-A85380', 'type': 'RADIATION', 'description': 'iv, single dose', 'armGroupLabels': ['2-[18F]-F-A85380']}]}, 'contactsLocationsModule': {'locations': [{'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 Södertälje'}, {'name': 'Ingemar, Bylesjö, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca CPU Huddinge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'AstraZeneca'}}}}