Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 8:11 AM
Study NCT ID:
NCT00411866
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2006-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007654', 'term': 'Ketoconazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2007-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2006-12-13', 'studyFirstSubmitQcDate': '2006-12-14', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood sampling over period of 336 hours post dosing with SB-773812', 'timeFrame': 'over period of 336 hours post dosing'}], 'secondaryOutcomes': [{'measure': 'Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.', 'timeFrame': 'over 48 hours post SB-773812 dosing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety', 'pharmacokinetics,'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/NAA105416?search=study&search_terms=NAA105416#rs', 'label': 'Results for study NAA105416 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy\n* Body Weight \\>/=50kg and BMI 18.5-29.9 kg/m2 inclusive\n* Normal 12-lead ECG, physical examination and lab screen\n\nExclusion criteria:\n\n* A history of psychiatric illness,\n* A history or presence gastro-intestinal,\n* A hepatic or renal disease or orthostatic hypotension.'}, 'identificationModule': {'nctId': 'NCT00411866', 'briefTitle': 'Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg', 'orgStudyIdInfo': {'id': 'NAA105416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects receiving ketoconazole for 8 days', 'description': 'In Session 1, subjects will receive a single oral dose of SB-773812 20 milligrams (mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 8 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.', 'interventionNames': ['Drug: SB773812', 'Drug: Ketoconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving ketoconazole for 14 days', 'description': 'In Session 1, subjects will receive a single oral dose of SB-773812 (20mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 12 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.', 'interventionNames': ['Drug: SB773812', 'Drug: Ketoconazole']}], 'interventions': [{'name': 'SB773812', 'type': 'DRUG', 'description': 'SB-773812 20 mg will be available as white round film coated tablets.', 'armGroupLabels': ['Subjects receiving ketoconazole for 14 days', 'Subjects receiving ketoconazole for 8 days']}, {'name': 'Ketoconazole', 'type': 'DRUG', 'otherNames': ['SB773812'], 'description': 'Ketoconazole will be available as 200mg tablets.', 'armGroupLabels': ['Subjects receiving ketoconazole for 14 days', 'Subjects receiving ketoconazole for 8 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}