Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 6:11 AM
Study NCT ID:
NCT00686504
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2008-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587779', 'term': 'AZD2066'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-08', 'studyFirstSubmitDate': '2008-05-27', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positron emission tomography using the radioligand radioligand [11C]AZ12713580', 'timeFrame': '4 times'}], 'secondaryOutcomes': [{'measure': 'To investigate the safety and tolerability of AZD2066 by assessment of Adverse Events (AEs), vital signs measurements (blood pressure and pulse), electrocardiogram (ECG), physical examination, clinical chemistry, haematology and urinalysis.', 'timeFrame': '7 visits with tests for all subjects. Some tests will be done several times per visit. All tests will not be performed at every visit.'}, {'measure': 'To investigate pharmacokinetics of AZD2066', 'timeFrame': '15 times per subject. Up to 48 hours each time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'PET', 'Phase 1', 'Analgesia', 'Positron Emission Tomography', 'mGlu5 receptor', 'Dose finding', 'Analgesia/Pain'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The study is carried out in order to determine the relationship between AZD2066 exposure and mGluR5 receptor occupancy in the brain and to demonstrate that AZD2066 can displace \\[11C\\]AZ12713580 from mGluR5 binding-sites in the Central Nervous System'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* BMI (Body Mass Index) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg\n* Normal MRI (Magnetic Resonance Imaging) scan at visit 2\n\nExclusion Criteria:\n\n* History of previous or ongoing psychiatric disease or condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders\n* History of psychotic disorder among first degree relatives (parents, siblings)\n* History of use of antipsychotic, antidepressant or anxiolytic (anxiety treatment) drugs, prescribed or non-prescribed use. History of antidepressants or anxiolytics for non-psychiatric conditions such as pain or post-operative insomnia is allowed'}, 'identificationModule': {'nctId': 'NCT00686504', 'acronym': 'PET', 'briefTitle': 'Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open Label, Non-randomized Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066 After Oral Administration to Healthy Subjects', 'orgStudyIdInfo': {'id': 'D0475C00013'}, 'secondaryIdInfos': [{'id': 'EudractCT 2008-000064-17'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'AZD2066', 'type': 'DRUG', 'description': 'single dose of oral dose, 3 times per subject'}, {'name': 'radioligand [11C] AZ12713580', 'type': 'DRUG', 'description': 'single dose of iv administered 4 times per subject (3 times together with AZD2066)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Bo Fransson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden'}, {'name': 'Sophia Bengtsson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia', 'oldOrganization': 'AstraZeneca R&D Södertälje, Sweden'}}}}