Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02641067
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2015-12-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592662', 'term': 'doravirine'}]}}, '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': "Sponsor's policy on authorship is consistent with the requirements outlined in the ICH-Good Clinical Practice guidelines. In summary, authorship should reflect significant contribution to the design and conduct of the trial, performance or interpretation of the analysis, and/or writing of the manuscript.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after drug administration', 'description': 'The population analyzed consisted of all participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Matched Control', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', '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 19.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], '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': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000', 'lowerLimit': '47.4', 'upperLimit': '87.8'}, {'value': '45.1', 'groupId': 'OG001', 'lowerLimit': '33.2', 'upperLimit': '61.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.43', 'ciLowerLimit': '1.00', 'ciUpperLimit': '2.04', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', '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': 'All 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 Postdose (C24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '943', 'groupId': 'OG000', 'lowerLimit': '710', 'upperLimit': '1250'}, {'value': '684', 'groupId': 'OG001', 'lowerLimit': '515', 'upperLimit': '908'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.38', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.92', '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': 'All 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': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '1580', 'groupId': 'OG000', 'lowerLimit': '1210', 'upperLimit': '2080'}, {'value': '1900', 'groupId': 'OG001', 'lowerLimit': '1450', 'upperLimit': '2500'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.83', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.15', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.', 'unitOfMeasure': 'nM', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 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 From 0 Hours to the Time of Last Quantifiable Sample of Doravirine (AUC 0-last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '56.3', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '29.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.', 'unitOfMeasure': 'μM•hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 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': 'Time to Maximum Observed Plasma Concentration (Tmax) of Doravirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All 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': 'Apparent Terminal Half-life (t1/2) of Plasma Doravirine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '25.02', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '16.69', 'spread': '26.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 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': 'Apparent Clearance of Plasma Doravirine After Extravascular Administration (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '3.53', 'spread': '63.9', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '32.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.', 'unitOfMeasure': 'Liter/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 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': 'Apparent Volume of Distribution of Plasma Doravirine During the Terminal Phase (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'OG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'spread': '40.9', 'groupId': 'OG000'}, {'value': '129', 'spread': '28.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 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': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'FG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral dose of 100 mg doravirine'}, {'id': 'BG001', 'title': 'Healthy Matched Controls', 'description': 'Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '19 to 49 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '50 to 59 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '60 to 69 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '90.86', 'spread': '17.409', 'groupId': 'BG000'}, {'value': '90.93', 'spread': '6.086', 'groupId': 'BG001'}, {'value': '90.89', 'spread': '12.599', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': '2016-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2015-12-23', 'resultsFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2015-12-23', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-26', 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', '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 Postdose (C24)', 'timeFrame': '24 hours postdose', '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': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', '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 From 0 Hours to the Time of Last Quantifiable Sample of Doravirine (AUC 0-last)', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) of Doravirine', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of Plasma Doravirine', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.'}, {'measure': 'Apparent Clearance of Plasma Doravirine After Extravascular Administration (CL/F)', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.'}, {'measure': 'Apparent Volume of Distribution of Plasma Doravirine During the Terminal Phase (Vz/F)', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment', 'description': 'Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Impairment']}, 'referencesModule': {'references': [{'pmid': '29891610', 'type': 'DERIVED', 'citation': 'Ankrom W, Yee KL, Sanchez RI, Adedoyin A, Fan L, Marbury T, Preston RA, Iwamoto M, Khalilieh SG. Severe Renal Impairment Has Minimal Impact on Doravirine Pharmacokinetics. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00326-18. doi: 10.1128/AAC.00326-18. Print 2018 Aug.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* is a non-smoker or moderate smoker\n* has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m\\^2\n* other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests\n* female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method\n* female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.\n* Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73m\\^2\n\nExclusion Criteria:\n\n* is mentally or legally incapacitated or has significant emotional problems\n* has a history or presence of clinically significant medical or psychiatric condition or disease\n* has history or presence of alcoholism or drug abuse within the past 2 years\n* has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds\n* has history or presence of renal artery stenosis\n* has had a renal transplant or nephrectomy\n* has rapidly fluctuating renal function as determined by historical measurements\n* female is pregnant or lactating\n* has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in\n* has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)\n* is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.\n* is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.\n* has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study\n* has donated blood or had significant blood loss within 56 days prior to dosing\n* has donated plasma within 7 days prior to dosing\n* has participated in another clinical trial within 28 days prior to dosing'}, 'identificationModule': {'nctId': 'NCT02641067', 'briefTitle': 'A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-1439 (Doravirine) in Subjects With Severe Renal Impairment', 'orgStudyIdInfo': {'id': '1439-051'}, 'secondaryIdInfos': [{'id': 'MK-1439-051', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe Renal Impairment', 'description': 'Participants with severe renal impairment receive a single oral dose of 100 mg doravirine', 'interventionNames': ['Drug: Doravirine']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Matched Control', 'description': 'Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine', 'interventionNames': ['Drug: Doravirine']}], 'interventions': [{'name': 'Doravirine', 'type': 'DRUG', 'otherNames': ['MK-1439, PIFELTRO'], 'description': 'Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally', 'armGroupLabels': ['Healthy Matched Control', 'Severe Renal Impairment']}]}, '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'}}}}