Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01565902
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2012-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of BAF312 in Patients With Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'interventionBrowseModule': {'meshes': [{'id': 'C578989', 'term': 'siponimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Moderate Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Severe Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Matched Healthy Subjects', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Mild Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG001', 'title': 'Moderate Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG002', 'title': 'Severe Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG003', 'title': 'Matched Healthy Subjects - Mild', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG004', 'title': 'Matched Healthy Subjects - Moderate', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG005', 'title': 'Matched Healthy Subjects - Severe', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}], 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '53.9', 'spread': '7.57', 'groupId': 'OG001'}, {'value': '73.7', 'spread': '25.4', 'groupId': 'OG002'}, {'value': '64.2', 'spread': '20.8', 'groupId': 'OG003'}, {'value': '63.2', 'spread': '18.6', 'groupId': 'OG004'}, {'value': '64.9', 'spread': '23.6', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.', 'description': 'The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG001', 'title': 'Moderate Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG002', 'title': 'Severe Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG003', 'title': 'Matched Healthy Subjects - Mild', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG004', 'title': 'Matched Healthy Subjects - Moderate', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG005', 'title': 'Matched Healthy Subjects - Severe', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}], 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '7.51', 'groupId': 'OG001'}, {'value': '71.6', 'spread': '24.5', 'groupId': 'OG002'}, {'value': '62.5', 'spread': '20.9', 'groupId': 'OG003'}, {'value': '61.7', 'spread': '18.7', 'groupId': 'OG004'}, {'value': '63.4', 'spread': '23.6', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.', 'description': 'The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG001', 'title': 'Moderate Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG002', 'title': 'Severe Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG003', 'title': 'Matched Healthy Subjects - Mild', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG004', 'title': 'Matched Healthy Subjects - Moderate', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG005', 'title': 'Matched Healthy Subjects - Severe', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '0.532', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.191', 'groupId': 'OG001'}, {'value': '1.58', 'spread': '0.304', 'groupId': 'OG002'}, {'value': '1.74', 'spread': '0.439', 'groupId': 'OG003'}, {'value': '1.80', 'spread': '0.417', 'groupId': 'OG004'}, {'value': '1.94', 'spread': '0.603', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose', 'description': 'The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose', 'unitOfMeasure': '(ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG001', 'title': 'Moderate Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG002', 'title': 'Severe Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'OG003', 'title': 'Matched Healthy Subjects', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}], 'classes': [{'title': 'At least one AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day -1 to 22', 'description': 'Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, α-fetoprotein \\[in hepatically impaired subjects only\\], pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, suicidality assessment (C-SSRS), (serious) adverse event monitoring.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consists of all subjects that received study drug and with no protocol deviations with relevant impact on safety.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mild Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'FG001', 'title': 'Moderate Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'FG002', 'title': 'Severe Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'FG003', 'title': 'Matched Healthy Subjects', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Up to forty-eight subjects were planned to be enrolled in four groups. A total of 40 subjects were enrolled and completed the study. All subjects were included in the safety and PK analysis. However, only 38 subjects were included for primary PK analysis based on matched pair analysis', 'preAssignmentDetails': 'To potentially reduce the number of healthy subjects exposed to BAF312, study allowed for multiple matching of subjects with hepatic impairment to healthy subjects. During the study, 2 healthy subjects were not matched to any of the subjects with hepatic impairment due to a retrospective identification of a better matching partner'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Mild Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'BG001', 'title': 'Moderate Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'BG002', 'title': 'Severe Hepatically Impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'BG003', 'title': 'Matched Healthy Subjects', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '6.20', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '6.30', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '3.41', 'groupId': 'BG002'}, {'value': '50.1', 'spread': '5.50', 'groupId': 'BG003'}, {'value': '50.7', 'spread': '5.65', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2012-03-26', 'resultsFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-12', 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'timeFrame': 'pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.', 'description': 'The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.'}, {'measure': 'Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)', 'timeFrame': 'pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.', 'description': 'The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.'}, {'measure': 'Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)', 'timeFrame': 'pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose', 'description': 'The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312', 'timeFrame': 'Day -1 to 22', 'description': 'Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, α-fetoprotein \\[in hepatically impaired subjects only\\], pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, suicidality assessment (C-SSRS), (serious) adverse event monitoring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BAF312', 'Pharmacokinetics', 'Hepatic impairment'], 'conditions': ['Hepatic Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.dustri.com/nc/article-response-page.html?artId=14609&doi=10.5414%2FCP202588', 'label': 'Publication from the International Journal of Clinical Pharmacology and Therapeutics'}, {'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13203', 'label': 'Results for CBAF312A2122 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects:\n\n* Male and female Caucasian subjects 18 to 70 years of age\n* At least 50 kg and body mass index (BMI) within 18-35 kg/m2.\n* CYP2C9 wild-type (CYP2C9\\*1 homozygous carriers)\n\nHepatic impairment:\n\n\\- Subjects must have either mild, moderate or severe hepatic impairment\n\nExclusion Criteria:\n\nAll subjects\n\n* Hepatic impairment due to non-liver disease.\n* Use of other investigational drugs within certain timelines\n* Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing\n* History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR \\< 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles \\>100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.\n* History of cardiac catheter ablation.\n* Women of child-bearing potential\n* History of malignancy of any organ system\n* Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)\n* History or presence of symptomatic postural hypotension or syncope.\n* Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count \\< 30,000/μL at screening or baseline.\n* Clinically significant infection or recent vaccination with live-attenuated vaccines.\n* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.\n* History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.\n\nHepatic impairment:\n\n* History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.\n* Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.\n* Treatment with certain drugs\n\nHealthy subjects:\n\n* History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.'}, 'identificationModule': {'nctId': 'NCT01565902', 'briefTitle': 'Pharmacokinetics of BAF312 in Patients With Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects.', 'orgStudyIdInfo': {'id': 'CBAF312A2122'}, 'secondaryIdInfos': [{'id': '2012-000562-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild hepatically impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'interventionNames': ['Drug: BAF312']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate hepatically impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'interventionNames': ['Drug: BAF312']}, {'type': 'EXPERIMENTAL', 'label': 'Severe hepatically impaired', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'interventionNames': ['Drug: BAF312']}, {'type': 'EXPERIMENTAL', 'label': 'Matched healthy subjects', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'interventionNames': ['Drug: BAF312']}], 'interventions': [{'name': 'BAF312', 'type': 'DRUG', 'description': 'Treatment with a single oral dose of 0.25 mg BAF312', 'armGroupLabels': ['Matched healthy subjects', 'Mild hepatically impaired', 'Moderate hepatically impaired', 'Severe hepatically impaired']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': '1076', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '115419', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}