Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT01010906
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2009-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540393', 'term': 'vaniprevir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after administration of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Mild Hepatic Insufficiency (HI)', 'description': 'Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Control for Mild HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Moderate HI', 'description': 'Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Healthy Control for Moderate HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Severe HI', 'description': 'Participants with severe HI administered a single 200 mg oral tablet of vaniprevir', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Healthy Control for Severe HI', 'description': 'Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypersplenism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Insufficiency (HI)', 'description': 'Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG001', 'title': 'Healthy Control for Mild HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG002', 'title': 'Moderate HI', 'description': 'Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG003', 'title': 'Healthy Control for Moderate HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG004', 'title': 'Severe HI', 'description': 'Participants with severe HI administered a single 200 mg oral tablet of vaniprevir'}, {'id': 'OG005', 'title': 'Healthy Control for Severe HI', 'description': 'Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir'}], 'classes': [{'categories': [{'measurements': [{'value': '2.68', 'groupId': 'OG000', 'lowerLimit': '1.39', 'upperLimit': '5.18'}, {'value': '1.48', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '2.59'}, {'value': '5.09', 'groupId': 'OG002', 'lowerLimit': '2.21', 'upperLimit': '11.70'}, {'value': '1.64', 'groupId': 'OG003', 'lowerLimit': '0.67', 'upperLimit': '3.98'}, {'value': '7.79', 'groupId': 'OG004', 'lowerLimit': '5.03', 'upperLimit': '12.00'}, {'value': '0.925', 'groupId': 'OG005', 'lowerLimit': '0.61', 'upperLimit': '1.41'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least-Square Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.82', 'ciLowerLimit': '0.96', 'ciUpperLimit': '3.43', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the 90% Confidence Interval falls within the interval \\[0.50, 2.00\\], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Least-Square Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.11', 'ciLowerLimit': '1.60', 'ciUpperLimit': '6.04', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the 90% Confidence Interval falls within the interval \\[0.50, 2.00\\], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Geometric Least-Square Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.42', 'ciLowerLimit': '5.20', 'ciUpperLimit': '13.64', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the 90% Confidence Interval falls within the interval \\[0.50, 2.00\\], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-48 hours postdose', 'description': 'Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.', 'unitOfMeasure': 'µM.hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants administered at least one dose of investigational drug. AUC for one participant with Mild HI was not estimated due to poor correlation of the linear regression.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild Hepatic Insufficiency (HI)', 'description': 'Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG001', 'title': 'Healthy Control for Mild HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG002', 'title': 'Moderate HI', 'description': 'Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG003', 'title': 'Healthy Control for Moderate HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'OG004', 'title': 'Severe HI', 'description': 'Participants with severe HI administered a single 200 mg oral tablet of vaniprevir'}, {'id': 'OG005', 'title': 'Healthy Control for Severe HI', 'description': 'Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir'}], 'classes': [{'categories': [{'measurements': [{'value': '0.922', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '1.94'}, {'value': '0.586', 'groupId': 'OG001', 'lowerLimit': '0.29', 'upperLimit': '1.17'}, {'value': '1.88', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '4.01'}, {'value': '0.852', 'groupId': 'OG003', 'lowerLimit': '0.38', 'upperLimit': '1.91'}, {'value': '2.06', 'groupId': 'OG004', 'lowerLimit': '1.37', 'upperLimit': '3.12'}, {'value': '0.335', 'groupId': 'OG005', 'lowerLimit': '0.23', 'upperLimit': '0.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least-Square Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.57', 'ciLowerLimit': '0.76', 'ciUpperLimit': '3.24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Least-Square Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.21', 'ciLowerLimit': '1.21', 'ciUpperLimit': '4.03', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Geometric Least-Square Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.16', 'ciLowerLimit': '3.90', 'ciUpperLimit': '9.71', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-48 hours postdose', 'description': 'Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.', 'unitOfMeasure': 'µM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants administered at least one dose of investigational drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mild Hepatic Insufficiency (HI)', 'description': 'Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'FG001', 'title': 'Healthy Control for Mild HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'FG002', 'title': 'Moderate HI', 'description': 'Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'FG003', 'title': 'Healthy Control for Moderate HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'FG004', 'title': 'Severe HI', 'description': 'Participants with severe HI administered a single 200 mg oral tablet of vaniprevir'}, {'id': 'FG005', 'title': 'Healthy Control for Severe HI', 'description': 'Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Mild Hepatic Insufficiency (HI)', 'description': 'Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'BG001', 'title': 'Healthy Control for Mild HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'BG002', 'title': 'Moderate HI', 'description': 'Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'BG003', 'title': 'Healthy Control for Moderate HI', 'description': 'Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir'}, {'id': 'BG004', 'title': 'Severe HI', 'description': 'Participants with severe HI administered a single 200 mg oral tablet of vaniprevir'}, {'id': 'BG005', 'title': 'Healthy Control for Severe HI', 'description': 'Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '5.03', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '3.54', 'groupId': 'BG001'}, {'value': '52.1', 'spread': '6.51', 'groupId': 'BG002'}, {'value': '53.3', 'spread': '4.90', 'groupId': 'BG003'}, {'value': '53.4', 'spread': '6.08', 'groupId': 'BG004'}, {'value': '52.6', 'spread': '7.04', 'groupId': 'BG005'}, {'value': '52.3', 'spread': '5.49', 'groupId': 'BG006'}]}]}], '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': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2010-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2009-11-06', 'resultsFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-26', 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration', 'timeFrame': '0-48 hours postdose', 'description': 'Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration', 'timeFrame': '0-48 hours postdose', 'description': 'Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=7009-005&kw=7009-005&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHepatic Participants:\n\n* Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study\n* Apart from hepatic insufficiency, is in good general health\n* Has a diagnosis of chronic stable hepatic insufficiency\n* Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). Moderate and Severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit.\n\nHealthy Matched Participants:\n\n* Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study\n* Is in good health\n\nExclusion Criteria:\n\n* Female is pregnant, lactating, expecting to become pregnant or donate eggs\n* Has a history of stroke or seizures\n* Has a history of cancer\n* Is unable to refrain from the use of any prescription or non-prescription medication\n* Consumes excessive amounts of alcohol or caffeinated beverages daily\n* Has had surgery, donated blood or participated in another investigational study with in the last 4 weeks\n* Is a regular user or past abuser of any illicit drug including alcohol'}, 'identificationModule': {'nctId': 'NCT01010906', 'briefTitle': 'A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009', 'orgStudyIdInfo': {'id': '7009-005'}, 'secondaryIdInfos': [{'id': '2009_674'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Insufficiency (HI)', 'description': 'Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir', 'interventionNames': ['Drug: Vaniprevir 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Control to Mild HI', 'description': 'Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir', 'interventionNames': ['Drug: Vaniprevir 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate HI', 'description': 'Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir', 'interventionNames': ['Drug: Vaniprevir 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Control to Moderate HI', 'description': 'Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir', 'interventionNames': ['Drug: Vaniprevir 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Severe HI', 'description': 'Participants with severe HI administered a single 200 mg oral tablet of vaniprevir', 'interventionNames': ['Drug: Vaniprevir 200 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Control to Severe HI', 'description': 'Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir', 'interventionNames': ['Drug: Vaniprevir 200 mg']}], 'interventions': [{'name': 'Vaniprevir 300 mg', 'type': 'DRUG', 'otherNames': ['MK-7009'], 'description': 'single dose administration of 300 mg oral tablet', 'armGroupLabels': ['Healthy Control to Mild HI', 'Healthy Control to Moderate HI', 'Mild Hepatic Insufficiency (HI)', 'Moderate HI']}, {'name': 'Vaniprevir 200 mg', 'type': 'DRUG', 'otherNames': ['MK-7009'], 'description': 'single dose administration of 200 mg oral tablet', 'armGroupLabels': ['Healthy Control to Severe HI', 'Severe HI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}