Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT00435695
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2007-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587791', 'term': '1-(3-(2-(4-(2-methyl-5-quinolinyl)-1-piperazinyl)ethyl)phenyl)-2-imidazolidinone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2007-02-13', 'studyFirstSubmitQcDate': '2007-02-13', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'Vitals signs ECGs Clinical Laboratory test results', 'timeFrame': 'throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PET scan', 'healthy males'], 'conditions': ['Healthy Subjects', 'Depressive Disorder and Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called \\[11C\\]-WAY100635.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects, aged 18-45 years Body weight \\> 50 kg\n* Non-Smoker\n* Normal ECG, heart rate and blood pressure\n\nExclusion Criteria:\n\n* History of any cardiac disease\n* History of regular alcohol consumption averaging \\>14 drinks/week\n* Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts\n* Positive for Hepatitis B and C, and HIV.\n* History of drug abuse.\n* Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden\n* Family history of cancer (one or more first-degree relative diagnosed before the age of 55).\n* Suffers from claustrophobia\n* History or presence of neurological or psychiatric conditions\n* Presence of a cardiac pacemaker or other implanted electronic device or metal implants'}, 'identificationModule': {'nctId': 'NCT00435695', 'briefTitle': 'Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open Label, Non-randomized Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain 5-HT1A Receptor Occupancy, Pharmacokinetics and Safety of Single Oral Doses of GSK163090, Using the Ligand [11C]-WAY100635.', 'orgStudyIdInfo': {'id': 'HTP103265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GSK163090', 'description': 'one infusion only', 'interventionNames': ['Drug: GSK163090']}], 'interventions': [{'name': 'GSK163090', 'type': 'DRUG', 'armGroupLabels': ['GSK163090']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 1R8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}