Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-26 @ 4:57 PM
Study NCT ID:
NCT01059851
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2010-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551624', 'term': 'suvorexant'}]}}, '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. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From administration of study drug through 14 days after administration of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Severe Renal Impairment (Part I)', 'description': 'Participants with severe renal impairment received a\n\nsingle dose of 20 mg open-label suvorexant.', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Participants (Part I)', 'description': 'Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'oligomenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment (Part I)', 'description': 'Participants with severe renal impairment received a\n\nsingle dose of 20 mg open-label suvorexant.'}, {'id': 'OG001', 'title': 'Healthy Participants (Part I)', 'description': 'Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.98', 'groupId': 'OG000', 'lowerLimit': '9.45', 'upperLimit': '15.20'}, {'value': '9.81', 'groupId': 'OG001', 'lowerLimit': '7.72', 'upperLimit': '12.47'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'AUC(0-∞) Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.22', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.60', 'groupDescription': 'The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.\n\nThe AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single oral dose would be similar between participants with renal impairment and healthy matched control participants.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'AUC(0-∞) GMR = AUC(0-∞) GM for Severe Renal Impairment Participants ÷ AUC(0-∞) GM for Healthy Participants.\n\nA 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the 90% CI for the AUC(0-∞) GMR was contained within the interval \\[0.50, 2.00\\], then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is greater than 0.50 and no more than 2.00.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose', 'description': 'Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\\[0-∞\\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\\[0-last\\]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).', 'unitOfMeasure': 'μM•hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants'}, {'type': 'PRIMARY', 'title': 'AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Moderate Renal Impairment (Part II)', 'description': 'Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}, {'id': 'OG001', 'title': 'Healthy Participants (Moderate Impairment Controls) (Part II)', 'description': 'Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}, {'id': 'OG002', 'title': 'Participants With Mild Renal Impairment (Part II)', 'description': 'Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}, {'id': 'OG003', 'title': 'Healthy Participants (Mild Impairment Controls) (Part II)', 'description': 'Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}], 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose', 'description': 'Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\\[0-∞\\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\\[0-last\\]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the decision to conduct Part II of study in moderate/mild renal impairment participants was conditional on results of AUC (0-∞) analysis in severe renal impairment participants (Part I). Based on results of Part I of study, Part II was not conducted and AUC(0-∞) analysis in moderate/mild renal impairment was not done.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment (Part I)', 'description': 'Participants with severe renal impairment received a\n\nsingle dose of 20 mg open-label suvorexant.'}, {'id': 'OG001', 'title': 'Healthy Participants (Part I)', 'description': 'Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From administration of study drug through 14 days after administration of study drug', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment (Part I)', 'description': 'Participants with severe renal impairment received a\n\nsingle dose of 20 mg open-label suvorexant.'}, {'id': 'OG001', 'title': 'Healthy Participants (Part I)', 'description': 'Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From administration of study drug through 14 days after administration of study drug', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Severe Renal Impairment (Part I)', 'description': 'Participants with severe renal impairment received a\n\nsingle dose of 20 mg open-label suvorexant.'}, {'id': 'FG001', 'title': 'Healthy Participants (Severe Impairment Controls) (Part I)', 'description': 'Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.'}, {'id': 'FG002', 'title': 'Participants With Moderate Renal Impairment (Part II)', 'description': 'Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}, {'id': 'FG003', 'title': 'Healthy Participants (Moderate Impairment Controls) (Part II)', 'description': 'Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}, {'id': 'FG004', 'title': 'Participants With Mild Renal Impairment (Part II)', 'description': 'Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}, {'id': 'FG005', 'title': 'Healthy Participants (Mild Impairment Controls) (Part II)', 'description': 'Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '16 participants were enrolled in Part I of the study. Because the primary hypothesis was met in Part I, no participants were enrolled in Part II of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Severe Renal Impairment (Part I)', 'description': 'Participants with severe renal impairment received a\n\nsingle dose of 20 mg open-label suvorexant.'}, {'id': 'BG001', 'title': 'Healthy Participants (Part I)', 'description': 'Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics were only presented for participants in Part I of the study (N=16). No participants were enrolled in Part II of the study.'}}, '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': '2010-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2010-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2010-01-28', 'resultsFirstSubmitDate': '2014-08-19', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-19', 'studyFirstPostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose', 'description': 'Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\\[0-∞\\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\\[0-last\\]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).'}, {'measure': 'AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose', 'description': 'Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\\[0-∞\\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\\[0-last\\]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).'}, {'measure': 'Number of Participants With an Adverse Event (AE)', 'timeFrame': 'From administration of study drug through 14 days after administration of study drug', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.'}, {'measure': 'Number of Participants Who Discontinued Study Due to an AE', 'timeFrame': 'From administration of study drug through 14 days after administration of study drug', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insomnia']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=4305-023&kw=4305-023&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of suvorexant both in participants with impaired renal function and in healthy participants.', 'detailedDescription': 'Study Design:\n\nThis study plans to enroll 16 participants in Part I (8 participants with severe renal impairment and a control group of 8 healthy participants) and 32 participants in Part II (8 participants with moderate renal impairment and a control group of 8 healthy participants; and 8 participants with mild renal impairment and a control group of 8 healthy participants).\n\nPart II will be conducted only if the primary hypothesis is not met in Part I and there is a significant difference in the PK of suvorexant between healthy participants and severe renal impairment participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nImpaired Renal Function Participants:\n\n* Females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control\n* Body Mass Index (BMI) ≤40 kg/m\\^2\n* Diagnosis of renal insufficiency\n\nHealthy Participants:\n\n* Females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control\n* Body Mass Index (BMI) ≤40 kg/m\\^2 and is matched for BMI ± 5 units to his/her corresponding renal participant\n* In general good health\n* Matched for age ± 10 years to his/her corresponding renal participant\n\nExclusion Criteria:\n\nImpaired Renal Function Participants:\n\n* Is mentally or legally incapacitated\n* History of a clinically significant psychiatric disorder over the last year\n* Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis\n* Has had a kidney transplant\n* Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases\n* History of cancer (Some exceptions apply)\n* Regular user of barbiturates or sleep aides\n* Consumes excessive amounts of alcohol (\\>2 drinks/day)\n* Consumes excessive amounts of caffeinated beverages (\\>6/day)\n* Has had major surgery within 4 weeks\n* Has a history of significant multiple and/or severe allergies\n* Has a history of cataplexy\n* Participant works a night shift and is not able to avoid night shift work during the study\n* Current or history of illicit drug abuse\n* Nursing mothers\n\nHealthy Participants:\n\n* Is mentally or legally incapacitated;\n* Has a history of stroke, chronic seizures, or major neurological disorder\n* Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases\n* History of cancer (Some exceptions apply)\n* Regular user of barbiturates or sleep aides\n* Consumes excessive amounts of alcohol (\\>2 drinks/day)\n* Consumes excessive amounts of caffeinated beverages (\\>6/day)\n* Has had major surgery within 4 weeks\n* Has a history of significant multiple and/or severe allergies\n* Has a history of cataplexy\n* Participant works a night shift and is not able to avoid night shift work during the study\n* Current or history of illicit drug abuse\n* Nursing mothers'}, 'identificationModule': {'nctId': 'NCT01059851', 'briefTitle': 'Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Impaired Renal Function', 'orgStudyIdInfo': {'id': '4305-023'}, 'secondaryIdInfos': [{'id': '2010_505', 'type': 'OTHER', 'domain': 'Merck Registration Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with Severe Renal Impairment (Part I)', 'description': 'Participants with severe renal impairment will receive a\n\nsingle dose of 20 mg open-label suvorexant during Part I of the\n\nstudy.', 'interventionNames': ['Drug: Suvorexant']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Participants (Severe Impairment Controls) (Part I)', 'description': 'Healthy participants matched to participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study.', 'interventionNames': ['Drug: Suvorexant']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with Moderate Renal Impairment (Part II)', 'description': 'Participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.', 'interventionNames': ['Drug: Suvorexant']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Participants (Moderate Impairment Controls) (Part II)', 'description': 'Healthy participants matched to participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.', 'interventionNames': ['Drug: Suvorexant']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with Mild Renal Impairment (Part II)', 'description': 'Participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.', 'interventionNames': ['Drug: Suvorexant']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Participants (Mild Impairment Controls) (Part II)', 'description': 'Healthy participants matched to participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.', 'interventionNames': ['Drug: Suvorexant']}], 'interventions': [{'name': 'Suvorexant', 'type': 'DRUG', 'otherNames': ['MK-4305'], 'description': 'single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with \\~240 mL of water after an 8 hour fast', 'armGroupLabels': ['Healthy Participants (Mild Impairment Controls) (Part II)', 'Healthy Participants (Moderate Impairment Controls) (Part II)', 'Healthy Participants (Severe Impairment Controls) (Part I)', 'Participants with Mild Renal Impairment (Part II)', 'Participants with Moderate Renal Impairment (Part II)', 'Participants with Severe Renal Impairment (Part I)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', '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'}}}}