Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-06-03 @ 8:58 AM
Study NCT ID:
NCT01390428
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2011-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'New Zealand', 'United States']}, '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': 'C578009', 'term': 'grazoprevir'}]}}, '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 proposed 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': '14 days after last dose (up to Day 24)', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.', 'otherNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.', 'otherNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': 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{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Rhinalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 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'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}], 'seriousEvents': [{'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'OG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '2.65'}, {'value': '1.42', 'groupId': 'OG001', 'lowerLimit': '0.912', 'upperLimit': '2.20'}, {'value': '1.61', 'groupId': 'OG002', 'lowerLimit': '0.791', 'upperLimit': '3.29'}, {'value': '0.321', 'groupId': 'OG003', 'lowerLimit': '0.157', 'upperLimit': '0.655'}, {'value': '1.17', 'groupId': 'OG004', 'lowerLimit': '0.541', 'upperLimit': '2.55'}, {'value': '0.0592', 'groupId': 'OG005', 'lowerLimit': '0.0273', 'upperLimit': '0.129'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '6.20', 'groupId': 'OG000', 'lowerLimit': '4.19', 'upperLimit': '9.18'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '2.53', 'upperLimit': '5.54'}, {'value': '4.21', 'groupId': 'OG002', 'lowerLimit': '2.48', 'upperLimit': '7.14'}, {'value': '0.874', 'groupId': 'OG003', 'lowerLimit': '0.515', 'upperLimit': '1.48'}, {'value': '3.00', 'groupId': 'OG004', 'lowerLimit': '1.71', 'upperLimit': '5.26'}, {'value': '0.257', 'groupId': 'OG005', 'lowerLimit': '0.146', 'upperLimit': '0.451'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.21', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.01', 'estimateComment': 'Mild Hepatic Impairment (HI)/Healthy Matched to Mild HI', 'groupDescription': 'Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.66', 'ciLowerLimit': '1.05', 'ciUpperLimit': '2.61', 'estimateComment': 'Mild HI/Healthy Matched to Mild HI', 'groupDescription': 'Day 10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.03', 'ciLowerLimit': '2.19', 'ciUpperLimit': '11.56', 'estimateComment': 'Moderate HI/Healthy Matched to Moderate HI', 'groupDescription': 'Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.82', 'ciLowerLimit': '2.60', 'ciUpperLimit': '8.93', 'estimateComment': 'Moderate HI/Healthy Matched to Moderate HI', 'groupDescription': 'Day 10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '19.83', 'ciLowerLimit': '8.11', 'ciUpperLimit': '48.51', 'estimateComment': 'Severe HI/Healthy Matched to Severe HI', 'groupDescription': 'Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.68', 'ciLowerLimit': '6.10', 'ciUpperLimit': '22.35', 'estimateComment': 'Severe HI/Healthy Matched to Severe HI', 'groupDescription': 'Day 10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 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'OG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'OG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'classes': [{'title': 'Day 1', 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'lowerLimit': '0.203', 'upperLimit': '0.774'}, {'value': '0.0304', 'groupId': 'OG005', 'lowerLimit': '0.0156', 'upperLimit': '0.0595'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.84', 'ciLowerLimit': '0.35', 'ciUpperLimit': '2.01', 'estimateComment': 'Mild HI/Healthy Matched to Mild HI', 'groupDescription': 'Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.37', 'ciLowerLimit': '0.83', 'ciUpperLimit': '2.27', 'estimateComment': 'Mild HI/Healthy Matched to Mild HI', 'groupDescription': 'Day 10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.64', 'ciLowerLimit': '2.74', 'ciUpperLimit': '21.27', 'estimateComment': 'Moderate HI/Healthy Matched to Moderate HI', 'groupDescription': 'Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.98', 'ciLowerLimit': '2.84', 'ciUpperLimit': '12.57', 'estimateComment': 'Moderate HI/Healthy Matched to Moderate HI', 'groupDescription': 'Day 10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '15.18', 'ciLowerLimit': '6.02', 'ciUpperLimit': '38.25', 'estimateComment': 'Severe HI/Healthy Matched to Severe HI', 'groupDescription': 'Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '13.01', 'ciLowerLimit': '6.00', 'ciUpperLimit': '28.21', 'estimateComment': 'Severe HI/Healthy Matched to Severe HI', 'groupDescription': 'Day 10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.', 'unitOfMeasure': 'uM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Time to Peak Concentration (Tmax) of Grazoprevir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'OG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '3.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '12.00'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '4.00'}, {'value': '1.75', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.75', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.50', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.01', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '8.00'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '1.75', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.', 'unitOfMeasure': 'hr.', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'OG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '25.2'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '13.5'}, {'value': '17.7', 'groupId': 'OG002', 'lowerLimit': '8.73', 'upperLimit': '35.8'}, {'value': '5.90', 'groupId': 'OG003', 'lowerLimit': '2.92', 'upperLimit': '11.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.86', 'ciLowerLimit': '1.54', 'ciUpperLimit': '2.24', 'estimateComment': 'Mild HI/Healthy Matched to Mild HI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.99', 'ciLowerLimit': '1.31', 'ciUpperLimit': '6.82', 'estimateComment': 'Moderate HI/Healthy Matched to Moderate HI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 at 24 hours postdose', 'description': 'Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.', 'unitOfMeasure': 'nM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Severe HI and Matched Healthy to Severe HI are absent because they had a different Measure Type and Method of Dispersion'}, {'type': 'PRIMARY', 'title': 'Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'OG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG004', 'lowerLimit': '2.89', 'upperLimit': '60.2'}, {'value': '1.86', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '3.32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 at 24 hours postdose', 'description': 'Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Mild HI, Moderate HI and Healthy Matched to Mild HI or Moderate HI are absent because they had a different Measure Type and Method of Dispersion'}, {'type': 'PRIMARY', 'title': 'Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'OG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '42.8'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '22.3'}, {'value': '48.9', 'groupId': 'OG002', 'lowerLimit': '27.2', 'upperLimit': '87.9'}, {'value': '13.6', 'groupId': 'OG003', 'lowerLimit': '7.60', 'upperLimit': '24.5'}, {'value': '55.0', 'groupId': 'OG004', 'lowerLimit': '31.9', 'upperLimit': '94.8'}, {'value': '5.89', 'groupId': 'OG005', 'lowerLimit': '3.42', 'upperLimit': '10.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.92', 'ciLowerLimit': '1.40', 'ciUpperLimit': '2.63', 'estimateComment': 'Mild HI/Healthy Matched to Mild HI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.59', 'ciLowerLimit': '1.81', 'ciUpperLimit': '7.11', 'estimateComment': 'Moderate HI/Healthy Matched to Moderate HI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.34', 'ciLowerLimit': '4.98', 'ciUpperLimit': '17.51', 'estimateComment': 'Severe HI/Healthy Matched to Severe HI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 10 at 24 hours postdose', 'description': 'Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.', 'unitOfMeasure': 'nM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t1/2) of Grazoprevir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'OG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'OG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.24', 'spread': '22.32', 'groupId': 'OG000'}, {'value': '35.85', 'spread': '47.15', 'groupId': 'OG001'}, {'value': '39.59', 'spread': '23.76', 'groupId': 'OG002'}, {'value': '39.80', 'spread': '17.34', 'groupId': 'OG003'}, {'value': '42.00', 'spread': '26.55', 'groupId': 'OG004'}, {'value': '31.02', 'spread': '41.99', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.', 'unitOfMeasure': 'hr.', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1-Mild Hepatic Impairment (HI)', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'FG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'FG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'FG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'FG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'FG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Elective Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1-Mild HI', 'description': 'Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'BG001', 'title': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.'}, {'id': 'BG002', 'title': 'Part 2-Moderate HI', 'description': 'Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'BG003', 'title': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.'}, {'id': 'BG004', 'title': 'Part 3-Severe HI', 'description': 'Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'BG005', 'title': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '6.7', 'groupId': 'BG002'}, {'value': '52.3', 'spread': '6.8', 'groupId': 'BG003'}, {'value': '52.1', 'spread': '8.4', 'groupId': 'BG004'}, {'value': '52.0', 'spread': '9.9', 'groupId': 'BG005'}, {'value': '53.1', 'spread': '6.9', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '38', '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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2011-07-07', 'resultsFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-03', 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir', 'timeFrame': 'Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.'}, {'measure': 'Maximum Concentration (Cmax) of Grazoprevir', 'timeFrame': 'Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.'}, {'measure': 'Time to Peak Concentration (Tmax) of Grazoprevir', 'timeFrame': 'Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.'}, {'measure': 'Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI', 'timeFrame': 'Day 1 at 24 hours postdose', 'description': 'Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.'}, {'measure': 'Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI', 'timeFrame': 'Day 1 at 24 hours postdose', 'description': 'Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.'}, {'measure': 'Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10', 'timeFrame': 'Days 10 at 24 hours postdose', 'description': 'Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of Grazoprevir', 'timeFrame': 'Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '28947470', 'type': 'RESULT', 'citation': 'Caro L, Wenning L, Guo Z, Fraser IP, Fandozzi C, Talaty J, Panebianco D, Ho M, Uemura N, Reitmann C, Angus P, Gane E, Marbury T, Smith WB, Iwamoto M, Butterton JR, Yeh WW. Effect of Hepatic Impairment on the Pharmacokinetics of Grazoprevir, a Hepatitis C Virus Protease Inhibitor. Antimicrob Agents Chemother. 2017 Nov 22;61(12):e00813-17. doi: 10.1128/AAC.00813-17. Print 2017 Dec.'}]}, 'descriptionModule': {'briefSummary': "This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* If female, must be of non-childbearing potential or willing to use at least 2 acceptable methods of contraception from enrollment to 2 weeks after the last dose of study drug\n* No clinically significant abnormality on electrocardiogram\n\nHepatic Insufficiency Participants Only:\n\n* Other than hepatic insufficiency with features of cirrhosis, is otherwise in good health based on medical history, physical examination, vital signs, and laboratory safety tests\n* Chronic (\\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology\n* Score on the Child-Pugh scale must range from 5 to 6 (mild hepatic insufficiency) to from 7 to 9 (moderate hepatic insufficiency) to from 10 to 15 (severe hepatic insufficiency)\n\nMatched Healthy Participants Only:\n\n\\- In good health based on medical history, physical examination, vital signs, and laboratory safety tests\n\nExclusion Criteria:\n\n* History of any illness that might confound the results of the study or poses an additional risk to the participant\n* History of clinically significant endocrine, gastrointestinal (other than related to their hepatic impairment), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases\n* Pregnancy\n* Estimated creatinine clearance of ≤60 mL/min\n* History of stroke, chronic seizures, or major neurological disorder\n* History of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment\n* Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort, green tea, gingko, coenzyme Q, ginseng, echinacea, etc.) or nutritional supplements (e.g., garlic supplements), beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study, until the poststudy visit\n* Participated in another investigational study within 4 weeks\n* History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n\nHepatic Insufficiency Participants Only:\n\n\\- Has a history of hepatitis C infection by serology, regardless of most recent viral load status.\n\nMatched Healthy Participants Only:\n\n* History of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any significant gastrointestinal surgery.\n* History of hepatitis C. Participants with a history of self-limited hepatitis A with complete resolution documented at least 6 months prior to entry will be eligible for inclusion"}, 'identificationModule': {'nctId': 'NCT01390428', 'briefTitle': 'Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label, 3-Part, Multiple Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172)', 'orgStudyIdInfo': {'id': '5172-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1-Mild Hepatic Impairment (HI)', 'description': 'Participants with mild hepatic impairment will receive 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.', 'interventionNames': ['Drug: Grazoprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1-Healthy Matched to Mild HI', 'description': 'Healthy participants will receive 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.', 'interventionNames': ['Drug: Grazoprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2-Moderate HI', 'description': 'Participants with moderate hepatic impairment will receive 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.', 'interventionNames': ['Drug: Grazoprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2-Healthy Matched to Moderate HI', 'description': 'Healthy participants will receive 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.', 'interventionNames': ['Drug: Grazoprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3-Severe HI', 'description': 'Participants with severe hepatic impairment will receive 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.', 'interventionNames': ['Drug: Grazoprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3-Healthy Matched to Severe HI', 'description': 'Healthy participants will receive 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.', 'interventionNames': ['Drug: Grazoprevir']}], 'interventions': [{'name': 'Grazoprevir', 'type': 'DRUG', 'description': 'Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days', 'armGroupLabels': ['Part 1-Healthy Matched to Mild HI', 'Part 1-Mild Hepatic Impairment (HI)', 'Part 2-Healthy Matched to Moderate HI', 'Part 2-Moderate HI', 'Part 3-Healthy Matched to Severe HI', 'Part 3-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'}}}}