Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT05386758
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2022-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000656703', 'term': 'molnupiravir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to ~ Day 15', 'description': 'All-cause mortality (ACM) was analyzed in all allocated participants. Safety Analyses were conducted in all participants who received at least 1 dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', '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 26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'OG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '11100', 'groupId': 'OG000', 'lowerLimit': '7990', 'upperLimit': '15400'}, {'value': '8960', 'groupId': 'OG001', 'lowerLimit': '7660', 'upperLimit': '10500'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Gemetric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.24', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.64', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose', 'description': 'Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of NHC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'OG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '3920', 'groupId': 'OG000', 'lowerLimit': '2810', 'upperLimit': '5460'}, {'value': '3240', 'groupId': 'OG001', 'lowerLimit': '2630', 'upperLimit': '4000'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.21', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.62', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose', 'description': 'Blood for plasma samples was collected at pre-specified time points to determine the Cmax of NHC.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced 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', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'OG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 15', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'OG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.72', 'spread': '50.9', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '172', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 4, 8, 12 and 24 hours postdose', 'description': 'Urine was collected at pre-specified time points to determine the amount of dose Administered excreted in urine (Ae) of NHC.', 'unitOfMeasure': 'mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Fraction of the Dose Administered Excreted in Urine (Fe) of NHC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'OG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.591', 'spread': '50.9', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '172', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 4, 8, 12 and 24 hours postdose', 'description': 'Urine was collected at pre-specified time points to determine the Fraction of the dose administered excreted in urine (Fe) of NHC.', 'unitOfMeasure': '% of administered dose', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance (CLr) of NHC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'OG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.338', 'spread': '62.1', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '162', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 4, 8, 12 and 24 hours postdose', 'description': 'Urine will be collected at pre-specified time points to determine the Renal Clearance (CLr) of NHC', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'FG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}], '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': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.'}, {'id': 'BG001', 'title': 'Healthy Participants With Normal Renal Function', 'description': 'Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-27', 'size': 2582897, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-19T15:54', 'hasProtocol': True}]}}, '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': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2022-05-18', 'resultsFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-19', 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)', 'timeFrame': 'Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose', 'description': 'Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of NHC', 'timeFrame': 'Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose', 'description': 'Blood for plasma samples was collected at pre-specified time points to determine the Cmax of NHC.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to Day 15', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.'}], 'secondaryOutcomes': [{'measure': 'Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC)', 'timeFrame': 'Predose, 4, 8, 12 and 24 hours postdose', 'description': 'Urine was collected at pre-specified time points to determine the amount of dose Administered excreted in urine (Ae) of NHC.'}, {'measure': 'Fraction of the Dose Administered Excreted in Urine (Fe) of NHC', 'timeFrame': 'Predose, 4, 8, 12 and 24 hours postdose', 'description': 'Urine was collected at pre-specified time points to determine the Fraction of the dose administered excreted in urine (Fe) of NHC.'}, {'measure': 'Renal Clearance (CLr) of NHC', 'timeFrame': 'Predose, 4, 8, 12 and 24 hours postdose', 'description': 'Urine will be collected at pre-specified time points to determine the Renal Clearance (CLr) of NHC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Impairment']}, 'referencesModule': {'references': [{'pmid': '39601078', 'type': 'RESULT', 'citation': 'Duncan KE, Carstens RP, Butterfield KL, Jin Y, Inbody LR, Schaeffer AK, Matthews CZ, Zhao T, Patel S, Maas BM, Cheng MH, Stoch SA. Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment. Clin Transl Sci. 2024 Dec;17(12):e70073. doi: 10.1111/cts.70073.'}], 'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. This study will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and the urinary excretion of NHC after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. The primary hypothesis is that the plasma PK participants with severe renal impairment will be similar to that observed in the healthy mean matched control participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe key Inclusion Criteria include but are not limited to the following:\n\n* Body mass index (BMI) ≥18.5 kg/m\\^2 and ≤35 kg/m\\^2\n* Healthy participants: Baseline estimated glomerular filtration rate (eGFR) ≥90 mL/min based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation\n* Severe renal impairment participants: Baseline estimated glomerular filtration rate (eGFR) \\<30 mL/min based on the 2021 CKD-EPI Creatinine equation\n\nExclusion Criteria:\n\nThe key Exclusion Criteria include but are not limited to the following:\n\n* Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)\n* History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit\n\nSevere renal impairment participants:\n\n* History or presence of renal artery stenosis\n* Had a renal transplant\n* Currently taking medications to treat chronic medical conditions associated with renal disease if participant has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of medication(s) within 4 hours prior to and 8 hours after administration of the study drug'}, 'identificationModule': {'nctId': 'NCT05386758', 'briefTitle': 'A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment', 'orgStudyIdInfo': {'id': '4482-003'}, 'secondaryIdInfos': [{'id': 'MK-4482-003', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A - Severe Renal Impairment Group', 'description': 'Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir.', 'interventionNames': ['Drug: Molnupiravir']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B - Healthy Control Group', 'description': 'Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir.', 'interventionNames': ['Drug: Molnupiravir']}], 'interventions': [{'name': 'Molnupiravir', 'type': 'DRUG', 'otherNames': ['MK-4482; MOV; EIDD-2801'], 'description': 'Four 200 mg capsules administered orally as a single dose', 'armGroupLabels': ['Panel A - Severe Renal Impairment Group', 'Panel B - Healthy Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'Velocity Clinical Research, Hallandale Beach ( Site 0005)', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33147', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma CR, LLC ( Site 0004)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Genesis Clinical Research, LLC ( Site 0003)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology ( Site 0001)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], '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://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}