Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT00690404
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C587779', 'term': 'AZD2066'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-08', 'studyFirstSubmitDate': '2008-06-02', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AZ2066 pharmacokinetics', 'timeFrame': 'several samples within 72 hrs'}], 'secondaryOutcomes': [{'measure': 'Effect of food on AZD2066 pharmacokinetics', 'timeFrame': 'several samples over 72 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['formulation', 'pharmacokinetic', 'crossover formulation', 'food effect', 'oral solution', 'healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical normal physical findings, including BP, pulse rate \\>45 bpm, ECG and laboratory assessments\n* Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg\n\nExclusion Criteria:\n\n* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.\n* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.'}, 'identificationModule': {'nctId': 'NCT00690404', 'briefTitle': 'AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 1, Single-center, Randomized, Open-label, Two-way Crossover, Formulation and Food Effect Study in Healthy Volunteers, to Assess the Pharmacokinetics of AZD 2066 After Single Doses of a New Oral Solid Formulation and an Oral Solution', 'orgStudyIdInfo': {'id': 'D0475C00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD2066']}], 'interventions': [{'name': 'AZD2066', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eleanor Lisbon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles, Inc. Overland Park, Kansas, USA'}, {'name': 'Heather Wray, MB, ChB, FFPM', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca Charnwood England'}, {'name': 'Ivan Eggens, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca , Södertälje, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rolf Karlsten, M.D., Medical Science Director, Emerging Neuroscience', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}