Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-09 @ 7:51 PM
Study NCT ID:
NCT00681720
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2008-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576237', 'term': '4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide'}, {'id': 'D005442', 'term': 'Flumazenil'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-20', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positron emission tomography using the radioligand (11C)flumazenil', 'timeFrame': '4 times per subject'}], 'secondaryOutcomes': [{'measure': 'To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables.', 'timeFrame': '6 visits with tests for the 2 subjects in the first group (Panel 1). 7 visits with tests for the 2 subjects in the second group (Panel 2). Some tests will be done several times per visit. All tests will not be done at every visit'}, {'measure': 'Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma', 'timeFrame': '3 times per subject. Up to 48 hours each time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anxiety', 'GABA receptors', 'Positron Emission Tomography', 'PET', 'phase I'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '28013354', 'type': 'DERIVED', 'citation': 'Jucaite A, Cselenyi Z, Lappalainen J, McCarthy DJ, Lee CM, Nyberg S, Varnas K, Stenkrona P, Halldin C, Cross A, Farde L. GABAA receptor occupancy by subtype selective GABAAalpha2,3 modulators: PET studies in humans. Psychopharmacology (Berl). 2017 Feb;234(4):707-716. doi: 10.1007/s00213-016-4506-4. Epub 2016 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg\n* Clinically normal physical findings, medical history and laboratory values.\n\nExclusion Criteria:\n\n* Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.\n* Intake of another investigational drug or participation in a clinical study the past 12 weeks.\n* Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.'}, 'identificationModule': {'nctId': 'NCT00681720', 'acronym': 'PET', 'briefTitle': 'Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325 After Oral Administration to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D1140C00007'}, 'secondaryIdInfos': [{'id': 'EudractCT 2007-005436-86'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD7325', 'Drug: Radioligand (11C) flumazenil']}], 'interventions': [{'name': 'AZD7325', 'type': 'DRUG', 'description': 'Single dose of oral solution or capsule. 3 times per subject.', 'armGroupLabels': ['1']}, {'name': 'Radioligand (11C) flumazenil', 'type': 'DRUG', 'description': 'Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)', 'armGroupLabels': ['1']}]}, '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': 'Eva Taavo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark A. Smith, MD, Medical Science Director, Emerging Psychiatry', 'oldOrganization': 'AstraZeneca'}}}}