Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-04-16 @ 4:45 AM
Study NCT ID:
NCT02089659
Status:
COMPLETED
Last Update Posted:
2018-12-28
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)
Sponsor:
Organization:
Raw JSON
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Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after drug administration', 'description': 'The population analyzed was all participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Participants With Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1: Healthy Control Participants', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Participants With Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.'}, {'id': 'OG001', 'title': 'Part 1: Healthy Control Participants', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '41.5', 'upperLimit': '70.0'}, {'value': '54.6', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '71.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.35', 'estimateComment': 'Moderate hepatic insufficiency / Healthy controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method', 'unitOfMeasure': 'µM*hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Doravirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Participants With Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.'}, {'id': 'OG001', 'title': 'Part 1: Healthy Control Participants', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1850', 'groupId': 'OG000', 'lowerLimit': '1420', 'upperLimit': '2420'}, {'value': '2050', 'groupId': 'OG001', 'lowerLimit': '1570', 'upperLimit': '2680'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.24', 'estimateComment': 'Moderate hepatic insufficiency / Healthy controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method', 'unitOfMeasure': 'nM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve Form 0 to 24 Hours (AUC0-24) of Doravirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Participants With Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.'}, {'id': 'OG001', 'title': 'Part 1: Healthy Control Participants', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '34.8'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': '37.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.93', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.18', 'estimateComment': 'Moderate hepatic insufficiency / Healthy controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, and 24 hours postdose', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method', 'unitOfMeasure': 'µM*hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Doravirine at 24 Hours (C24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Participants With Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.'}, {'id': 'OG001', 'title': 'Part 1: Healthy Control Participants', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '842', 'groupId': 'OG000', 'lowerLimit': '658', 'upperLimit': '1080'}, {'value': '847', 'groupId': 'OG001', 'lowerLimit': '662', 'upperLimit': '1080'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.33', 'estimateComment': 'Moderate hepatic insufficiency / Healthy controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours postdose', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method', 'unitOfMeasure': 'nM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Participants With Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.'}, {'id': 'FG001', 'title': 'Part 1: Healthy Control Participants', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.'}, {'id': 'FG002', 'title': 'Part 2: Participants With Mild Hepatic Insufficiency', 'description': 'Participants with mild hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have mild hepatic insufficiency based on the Child-Pugh scale. This arm was to be enrolled and investigated only if a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Part 2 of the study was to enroll participants only if a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1. Because this was not observed, no participants were enrolled in Part 2 of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Participants With Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency received a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.'}, {'id': 'BG001', 'title': 'Part 1: Healthy Control Participants', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine on Day 1 of Part 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '64'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '63'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Child-Pugh Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Total Score = 7', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Total Score = 8', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Total Score = 9', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Child-Pugh scale was used to classify the severity of liver disease in study participants. The total score is the sum of the scores on 5 clinical measures of liver disease, each on a 3-point scale where 3 is greatest severity: total bilirubin, serum albumin, INR, ascites, and hepatic encephalopathy. The total Child-Pugh score ranges from 5 to 15, where a score of 7 to 9 represents moderate hepatic insufficiency.', 'unitOfMeasure': 'Participants', 'populationDescription': 'All enrolled participants. Healthy participants were not evaluated for Child-Pugh scores.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'BG000', 'lowerLimit': '55.6', 'upperLimit': '119.0'}, {'value': '79.8', 'groupId': 'BG001', 'lowerLimit': '66.0', 'upperLimit': '92.1'}, {'value': '80.9', 'groupId': 'BG002', 'lowerLimit': '55.6', 'upperLimit': '119.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'All enrolled participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2014-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2014-03-14', 'resultsFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-03', 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine', 'timeFrame': 'Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Doravirine', 'timeFrame': 'Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve Form 0 to 24 Hours (AUC0-24) of Doravirine', 'timeFrame': 'Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, and 24 hours postdose', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method'}, {'measure': 'Plasma Concentration of Doravirine at 24 Hours (C24)', 'timeFrame': '24 hours postdose', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '28026013', 'type': 'RESULT', 'citation': 'Khalilieh S, Yee KL, Liu R, Fan L, Sanchez RI, Auger P, Triantafyllou I, Stypinski D, Lasseter KC, Marbury T, Iwamoto M. Moderate Hepatic Impairment Does Not Affect Doravirine Pharmacokinetics. J Clin Pharmacol. 2017 Jun;57(6):777-783. doi: 10.1002/jcph.857. Epub 2016 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 was to evaluate PK of doravirine in participants with mild hepatic insufficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) between 19 and 40 kg/m\\^2\n* Continuous non-smoker or moderate smoker of \\<20 cigarettes or equivalent per day. Agrees to consume \\<=10 cigarettes or equivalent per day from the time of screening through the period of sample collection.\n* In good health and with no clinically significant electrocardiogram abnormality\n* Hepatic impairment participants: diagnosis of chronic (\\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Part 1 only: score of 7 to 9 on the Child-Pugh scale. Part 2: score of 5 to 6 on the Child-Pugh scale.\n* Females of childbearing potential: sexually inactive for \\>=14 days before study drug administration and throughout the study, or using 2 acceptable methods of barrier contraception from screening until 14 days after study drug administration.\n\nExclusion Criteria:\n\n* Mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the study\n* History or presence of clinically significant medical or psychiatric condition or disease\n* History or presence of drug abuse within the past 2 years\n* History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds\n* Female participant who is pregnant or lactating\n* Positive results for breath alcohol or urine drug screen (unless due to prescription drug use and is approved by the investigator) at screening\n* Positive for HIV at screening\n* Unable to refrain from or anticipates the use of any drug known to be a significant inhibitor or inducer of cytochrome oxidase CYP3A or P-glycoprotein, or any medication or substance which cannot be discontinued at least 14 days before study drug administration and throughout the study.\n* Donation of \\>500 mL of blood or had significant blood loss within 56 days before study drug administration\n* Plasma donation within 7 days before study drug administration\n* Dosed in another clinical trial within 28 days before study drug administration\n* Healthy control participants only: positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening;'}, 'identificationModule': {'nctId': 'NCT02089659', 'briefTitle': 'A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A 2-Part, Open-Label, Singe-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-1439', 'orgStudyIdInfo': {'id': '1439-019'}, 'secondaryIdInfos': [{'id': 'MK-1439-019', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Moderate Hepatic Insufficiency', 'description': 'Participants with moderate hepatic insufficiency receive a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale.', 'interventionNames': ['Drug: Doravirine']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Healthy Matched Control', 'description': 'Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine on Day 1 of Part 1.', 'interventionNames': ['Drug: Doravirine']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Mild Hepatic Insufficiency', 'description': 'Participants with mild hepatic insufficiency receive a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have mild hepatic insufficiency based on the Child-Pugh scale. This arm was to be enrolled and investigated only if a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1.', 'interventionNames': ['Drug: Doravirine']}], 'interventions': [{'name': 'Doravirine', 'type': 'DRUG', 'otherNames': ['MK-1439'], 'description': 'Following an overnight fast, a single tablet of 100 mg doravirine was be administered orally', 'armGroupLabels': ['Part 1: Healthy Matched Control', 'Part 1: Moderate Hepatic Insufficiency', 'Part 2: Mild Hepatic Insufficiency']}]}, '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': 'http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}