Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-03-06 @ 6:38 PM
Study NCT ID:
NCT00750802
Status:
COMPLETED
Last Update Posted:
2009-06-26
First Post:
2008-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584463', 'term': '4-amino-8-(2,5-dimethoxyphenyl)-N-propylcinnoline-3-carboxamide'}, {'id': 'D008140', 'term': 'Lorazepam'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-25', 'studyFirstSubmitDate': '2008-09-10', 'studyFirstSubmitQcDate': '2008-09-10', 'lastUpdatePostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests', 'timeFrame': 'Test batteries will be performed at specified times both before and following study drug administration'}], 'secondaryOutcomes': [{'measure': 'Evaluation and characterization of the pharmacokinetics of AZD6280', 'timeFrame': 'Blood samples will be taken during the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I'], 'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on sleepiness, concentration and brain activity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects aged 18 to 55 years (inclusive) on Day 1.\n* Female subjects must be of non-child bearing potential.\n\nExclusion Criteria:\n\n* Clinically significant illness within 2 weeks before the study start.\n* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit\n* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2\n* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis'}, 'identificationModule': {'nctId': 'NCT00750802', 'briefTitle': 'A Sedation/Cognition/EEG Study Using AZD6280 and Comparator', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 1, Single Centre, Single Dose, Double-Blind, Double-Dummy, Four-Way Crossover, Placebo-Controlled, Randomized Study to Investigate the Effects of AZD6280 on Sedation, Cognition and EEG in Comparison With Lorazepam in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D0850C00014'}, 'secondaryIdInfos': [{'id': 'Eudract # 2008-001757-17'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD6280']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: AZD6280']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Lorazepam']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD6280', 'type': 'DRUG', 'description': '10mg Capsule, oral, single-dose', 'armGroupLabels': ['1']}, {'name': 'AZD6280', 'type': 'DRUG', 'description': '40mg Capsule, oral, single-dose', 'armGroupLabels': ['2']}, {'name': 'Lorazepam', 'type': 'DRUG', 'otherNames': ['Ativan'], 'description': '2mg tablet, oral single-dose', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Smith, MD, MSD, Emerging Psychiatry', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}