{ "FullStudy":{ "Rank":218105, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512667", "OrgStudyIdInfo":{ "OrgStudyId":"0822-067" }, "Organization":{ "OrgFullName":"Merck Sharp & Dohme Corp.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)", "OfficialTitle":"A Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Renal Insufficiency" }, "StatusModule":{ "StatusVerifiedDate":"July 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 17, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 22, 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 22, 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 12, 2017", "ResultsFirstSubmitQCDate":"August 17, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"February 26, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"July 30, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 28, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Merck Sharp & Dohme Corp.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib administered to participants with impaired renal/kidney function to those of a healthy matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Renal Insufficiency" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"25", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Severe Renal Insufficiency Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: MK-0822" ] } },{ "ArmGroupLabel":"Healthy Matched Control Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: MK-0822" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"MK-0822", "InterventionDescription":"A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Healthy Matched Control Group", "Severe Renal Insufficiency Group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "odanacatib" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose", "PrimaryOutcomeDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.", "PrimaryOutcomeTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Maximum Concentration (Cmax) of MK-0822 After Single Dose", "SecondaryOutcomeDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.", "SecondaryOutcomeTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose" },{ "SecondaryOutcomeMeasure":"Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose", "SecondaryOutcomeDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.", "SecondaryOutcomeTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose" },{ "SecondaryOutcomeMeasure":"Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose", "SecondaryOutcomeDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.", "SecondaryOutcomeTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nNot currently pregnant, nursing or planning to be pregnant through-out the course of the study; individual agrees to use specified contraception per protocol requirement for duration of study. Note: All females must have a serum pregnancy test to ensure and document negative test results prior to inclusion in the study.\nBody Mass Index (BMI) of up to 39.49kg/m^2\nAssessed to be in good health, including no clinically significant cardiac abnormalities based on results from an electrocardiogram (ECG) performed at pre-screening and/or prior to administration of study drug.\nMeets the requirements of the study in regard to current medication profile including: prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and nutritional products; with expected non-use of recreational (illicit) drugs associated with misuse, abuse and/or addiction.\nAgrees to adhere to all smoking and dietary restrictions associated with the study.\nPossess the ability to understand the study, grant voluntary informed consent, and willingly comply with all study requirements.\n\nInclusion Criterion Specific to Participants with Renal/Kidney Insufficiency:\n\nCreatinine clearance of <30 mL/min\n\nInclusion Criterion Specific to Healthy Volunteers:\n\nCreatine clearance of ≥ 90 mL/min (for healthy volunteers)\n\nExclusion Criteria:\n\nDoes not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, and/or a history of a clinically significant psychiatric disorder.\nDiagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results.\nHas demonstrated or suspected stenosis (narrowing) of the renal artery, and/or has had a renal transplant and/or kidney removal.\nHas current, unstable, significant organ system disease(s) and/or cancer(s).\nHas had a surgical procedure, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product.\nUnable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs and/or herbal remedies. Exceptions may include medications prescribed for prevention of disease or preservation of a healthy life.\nUses any medication or agent that has the potential to significantly alter renal/kidney function.\nUnable to avoid taking diuretics (within 4 hours prior to and after dosing with the investigational product) or phosphate binders containing aluminum, calcium or lanthanum salts; iron supplements or other metal cations; antacids; or multivitamins containing iron or zinc (within 8 hours prior to dosing and 4 hours after dosing with the investigational product). Note: individuals prescribed to diuretics must be on a stable dose for at least 4 weeks prior to the study's start date in order to participate.\nHistory of multiple and/or severe allergies, has had a life-threatening reaction to a drug or other agent, and/or inability to tolerate prescription or nonprescription drugs and/or food.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"79 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Merck Sharp & Dohme Corp.", "OverallOfficialRole":"Study Director" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Yes", "IPDSharingDescription":"https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf", "IPDSharingURL":"http://engagezone.msd.com/ds_documentation.php" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Severe Renal Insufficiency Group", "FlowGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Healthy Matched Control Group", "FlowGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"13" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"12" } ] } },{ "FlowMilestoneType":"Matched Participants", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"12" } ] } },{ "FlowMilestoneType":"Unmatched Participants", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Participant was not matched to a healthy control participant.", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"13" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"12" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Severe Renal Insufficiency Group", "BaselineGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Healthy Matched Control Group", "BaselineGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"13" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"12" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"25" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"62.8", "BaselineMeasurementSpread":"10.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"55.6", "BaselineMeasurementSpread":"10.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"59.4", "BaselineMeasurementSpread":"10.9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose", "OutcomeMeasureDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.", "OutcomeMeasurePopulationDescription":"The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"μM*hr", "OutcomeMeasureTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Severe Renal Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Healthy Matched Control Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"51.47", "OutcomeMeasurementLowerLimit":"38.96", "OutcomeMeasurementUpperLimit":"67.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"32.12", "OutcomeMeasurementLowerLimit":"24.60", "OutcomeMeasurementUpperLimit":"41.95" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (severe renal insufficiency / healthy) and 90% confidence intervals.", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"Similarity will be concluded if the GMR (severe renal insufficiency / healthy) is contained within the interval [0.40, 2.50].", "OutcomeAnalysisParamType":"GMR", "OutcomeAnalysisParamValue":"1.60", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.15", "OutcomeAnalysisCIUpperLimit":"2.23" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Maximum Concentration (Cmax) of MK-0822 After Single Dose", "OutcomeMeasureDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.", "OutcomeMeasurePopulationDescription":"The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"nM", "OutcomeMeasureTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Severe Renal Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Healthy Matched Control Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"359.85", "OutcomeMeasurementLowerLimit":"300.29", "OutcomeMeasurementUpperLimit":"431.22" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"246.09", "OutcomeMeasurementLowerLimit":"206.91", "OutcomeMeasurementUpperLimit":"292.69" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (severe renal insufficiency / healthy) and 90% confidence intervals.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"GMR", "OutcomeAnalysisParamValue":"1.46", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.18", "OutcomeAnalysisCIUpperLimit":"1.81" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose", "OutcomeMeasureDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.", "OutcomeMeasurePopulationDescription":"The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"hr", "OutcomeMeasureTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Severe Renal Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Healthy Matched Control Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.01", "OutcomeMeasurementLowerLimit":"2.00", "OutcomeMeasurementUpperLimit":"96.23" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.02", "OutcomeMeasurementLowerLimit":"2.00", "OutcomeMeasurementUpperLimit":"96.00" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose", "OutcomeMeasureDescription":"For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.", "OutcomeMeasurePopulationDescription":"The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"Geometric Coefficient of Variation", "OutcomeMeasureUnitOfMeasure":"hr", "OutcomeMeasureTimeFrame":"Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Severe Renal Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Healthy Matched Control Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"73.9", "OutcomeMeasurementSpread":"25.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"80.0", "OutcomeMeasurementSpread":"20.7" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Up to 15 days", "EventsDescription":"The safety population consisted of all participants who received at least one dose of the study drug.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Severe Renal Insufficiency Group", "EventGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"13", "EventGroupOtherNumAffected":"6", "EventGroupOtherNumAtRisk":"13" },{ "EventGroupId":"EG001", "EventGroupTitle":"Healthy Matched Control Group", "EventGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"12", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"12" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"13" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"13" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Gastrooesophageal reflux disease", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"13" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Toothache", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"13" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Bronchitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"13" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Urethritis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"13" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"12" } ] } },{ "OtherEventTerm":"Eye injury", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"13" },{ 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