Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT03507569
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2018-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042957', 'term': 'Ro 15-4513'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From treatment initiation until 14 days after the last dose of study treatment.', 'description': 'All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'RO7017773 - 15mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RO7017773 - 30mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'RO7017773 - 75mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'RO7017773 - 375mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Catheter site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Catheter site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Muscle contractions involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RO7017773 - 15mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission 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\\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}], 'timeFrame': 'Baseline up to 48 hours (hrs)', 'reportingStatus': 'POSTED', 'populationDescription': 'This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of RO7017773', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RO7017773 - 15mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission 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\\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}], 'timeFrame': 'Baseline up to 48 hrs', 'reportingStatus': 'POSTED', 'populationDescription': 'This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RO7017773 - 15mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'OG001', 'title': 'RO7017773 - 30mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'OG002', 'title': 'RO7017773 - 75mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'OG003', 'title': 'RO7017773 - 375mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment initiation until 14 days after the last dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RO7017773 - 15mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'FG001', 'title': 'RO7017773 - 30mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'FG002', 'title': 'RO7017773 - 75mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'FG003', 'title': 'RO7017773 - 375mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy subjects between the ages of 23 and 55 years (inclusive) were enrolled at one site in the United Kingdom.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'RO7017773 - 15mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'BG001', 'title': 'RO7017773 - 30mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'BG002', 'title': 'RO7017773 - 75mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'BG003', 'title': 'RO7017773 - 375mg', 'description': 'Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \\[11C\\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-08', 'size': 12405211, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-21T16:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-30', 'studyFirstSubmitDate': '2018-04-16', 'resultsFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-30', 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773', 'timeFrame': 'Baseline up to 48 hours (hrs)'}, {'measure': 'Plasma Concentrations of RO7017773', 'timeFrame': 'Baseline up to 48 hrs'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From treatment initiation until 14 days after the last dose of study treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemisty, serology, and urinalysis), as judged by the Investigator.\n* Males and women of non-childbearing potential (WONCBP)\n\nExclusion Criteria:\n\n* History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections\n* Clinically significant abnormal finding from the MRI performed after the initial screening examination\n* Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg\n* Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm\n* History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease\n* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies\n* Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment'}, 'identificationModule': {'nctId': 'NCT03507569', 'briefTitle': 'Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Non-Randomized Open Label, Adaptive, Parallel Group, Human Positron Emission Tomography (PET) Study to Assess Occupancy of Brain alpha5-Containing GABAA Receptors of Ro7017773 Using [11C] Ro15-4513 Following Single Oral Doses in Healthy Participants', 'orgStudyIdInfo': {'id': 'BP40257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RO7017773', 'description': 'The first two participants of the first cohort are anticipated to receive a single dose of RO7017773 orally. The doses to be tested in the subsequent cohorts of participants will be determined by review of PET scan, PK, and safety results from the previous dose level.', 'interventionNames': ['Drug: RO7017773', 'Other: [11C] Ro15-4513']}], 'interventions': [{'name': 'RO7017773', 'type': 'DRUG', 'description': 'RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.', 'armGroupLabels': ['RO7017773']}, {'name': '[11C] Ro15-4513', 'type': 'OTHER', 'description': 'At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer \\[11C\\]Ro15-4513.', 'armGroupLabels': ['RO7017773']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research; Central Middlesex Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}