{ "FullStudy":{ "Rank":218103, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512693", "OrgStudyIdInfo":{ "OrgStudyId":"0822-070" }, "Organization":{ "OrgFullName":"Merck Sharp & Dohme Corp.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)", "OfficialTitle":"Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Hepatic Insufficiency" }, "StatusModule":{ "StatusVerifiedDate":"July 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 23, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 24, 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 24, 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 12, 2017", "ResultsFirstSubmitQCDate":"June 12, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"October 27, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"July 30, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 29, 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 open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hepatic Insufficiency" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"17", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Moderate Hepatic Insufficiency Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic 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", "Moderate Hepatic 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 moderate hepatic 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 moderate hepatic 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 moderate hepatic 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":"Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.", "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; agree to use specified contraception per protocol requirement\nBody Mass Index (BMI) of ≤ 39 kg/m^2 (not obese)\nJudged to be in good health (for healthy participant population)\nNon-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study Investigator, quit smoking within the past 3 months.\nDiagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population)\nPossess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements\n\nExclusion Criteria:\n\nDoes not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder\nHas been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results\nCompromised renal (kidney) function, significant organ system disease(s) or cancer(s)\nUnable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies\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\nHad surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product\nHistory of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 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":"Moderate Hepatic Insufficiency Group", "FlowGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic 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":"8" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"9" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"8" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"8" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Moderate Hepatic Insufficiency Group", "BaselineGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic 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":"8" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"9" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"17" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53.1", "BaselineMeasurementSpread":"4.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"54.2", "BaselineMeasurementSpread":"5.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"53.7", "BaselineMeasurementSpread":"5.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"15" } ] } } ] } } ] } } ] } }, "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 moderate hepatic 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 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":"Moderate Hepatic Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic 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":"8" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28.84", "OutcomeMeasurementLowerLimit":"21.88", "OutcomeMeasurementUpperLimit":"38.01" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"33.79", "OutcomeMeasurementLowerLimit":"25.64", "OutcomeMeasurementUpperLimit":"44.54" } ] } } ] } } ] }, "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 (moderate hepatic 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) (moderate hepatic insufficiency / healthy) and 90% confidence intervals.", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"Similarity will be concluded if the GMR (moderate hepatic insufficiency / healthy) is contained within the interval [0.40, 2.50].", "OutcomeAnalysisParamType":"GMR", "OutcomeAnalysisParamValue":"0.85", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.61", "OutcomeAnalysisCIUpperLimit":"1.19" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Maximum Concentration (Cmax) of MK-0822 After Single Dose", "OutcomeMeasureDescription":"For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.", "OutcomeMeasurePopulationDescription":"The per protocol population consisted of all 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":"Moderate Hepatic Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic 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":"8" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"199.41", "OutcomeMeasurementLowerLimit":"150.26", "OutcomeMeasurementUpperLimit":"264.64" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"279.59", "OutcomeMeasurementLowerLimit":"210.68", "OutcomeMeasurementUpperLimit":"371.05" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (moderate hepatic insufficiency / healthy) and 90% confidence intervals.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"GMR", "OutcomeAnalysisParamValue":"0.71", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.51", "OutcomeAnalysisCIUpperLimit":"1.00" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose", "OutcomeMeasureDescription":"For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.", "OutcomeMeasurePopulationDescription":"The per protocol population consisted of all 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":"Moderate Hepatic Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic 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":"8" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.00", "OutcomeMeasurementLowerLimit":"2.00", "OutcomeMeasurementUpperLimit":"48.00" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24.00", "OutcomeMeasurementLowerLimit":"2.00", "OutcomeMeasurementUpperLimit":"48.00" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose", "OutcomeMeasureDescription":"Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.", "OutcomeMeasurePopulationDescription":"The per protocol population consisted of all 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":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "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":"Moderate Hepatic Insufficiency Group", "OutcomeGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic 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":"8" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"91.5", "OutcomeMeasurementSpread":"30.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"70.5", "OutcomeMeasurementSpread":"10.2" } ] } } ] } } ] } } ] } }, "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":"Moderate Hepatic Insufficiency Group", "EventGroupDescription":"Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"8", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"8" },{ "EventGroupId":"EG001", "EventGroupTitle":"Healthy Matched Control Group", "EventGroupDescription":"Single-dose administration of odanacatib 50 mg to healthy matched control participants.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"9", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"9" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Nasopharynigitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"8" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA v. 15.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"8" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"GT60", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Senior Vice President, Global Clinical Development", "PointOfContactOrganization":"Merck Sharp & Dohme Corp.", "PointOfContactEMail":"ClinicalTrialsDisclosure@merck.com", "PointOfContactPhone":"1-800-672-6372" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "United States" ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000048550", "ConditionMeshTerm":"Hepatic Insufficiency" },{ "ConditionMeshId":"D000017093", "ConditionMeshTerm":"Liver Failure" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000008107", "ConditionAncestorTerm":"Liver Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M17998", "ConditionBrowseLeafName":"Liver Failure", "ConditionBrowseLeafAsFound":"Hepatic Insufficiency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M24557", "ConditionBrowseLeafName":"Hepatic Insufficiency", "ConditionBrowseLeafAsFound":"Hepatic Insufficiency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }