[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659347":3},{"organization":4,"outcomesModule":7,"designInfo":135,"detailedDescription":134,"studyPopulation":134,"armGroups":141,"interventions":150,"overallOfficials":164,"centralContacts":134,"locations":134,"responsibleParty":168,"collaborators":134,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":134,"eligibilityCriteria":176,"healthyVolunteers":177,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":134,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":134,"overallStatus":190,"whyStopped":134,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":134},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":134},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Period 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam","Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.","Predose and at designated timepoints up to approximately 24 hours",{"measure":14,"description":11,"timeFrame":15},"Period 2: AUC0-inf of Midazolam","Predose and at designated timepoints up to approximately Day 15",{"measure":17,"description":18,"timeFrame":19},"Period 1: AUC0-inf of Rosuvastatin","Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.","Predose and at designated timepoints up to approximately 96 hours",{"measure":21,"description":18,"timeFrame":22},"Period 2: AUC0-inf of Rosuvastatin","Predose and at designated timepoints up to approximately Day 19",[24,27,29,32,34,37,39,42,44,47,49,52,54,57,59,62,64,67,69,72,74,77,79,82,84,87,89,92,94,97,99,102,104,107,109,113,117,121,124,127,130,132],{"measure":25,"description":26,"timeFrame":12},"Period 1: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)","Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam metabolite (1-hydroxymidazolam).",{"measure":28,"description":26,"timeFrame":15},"Period 2: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)",{"measure":30,"description":31,"timeFrame":12},"Period 1: Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam","Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam.",{"measure":33,"description":31,"timeFrame":15},"Period 2: AUC0-last of Midazolam",{"measure":35,"description":36,"timeFrame":12},"Period 1: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)","Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam metabolite (1-hydroxymidazolam).",{"measure":38,"description":36,"timeFrame":15},"Period 2: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)",{"measure":40,"description":41,"timeFrame":12},"Period 1: Maximum Plasma Concentration (Cmax) of Midazolam","Blood samples will be collected at multiple time points to determine the Cmax of midazolam.",{"measure":43,"description":41,"timeFrame":15},"Period 2: Cmax of Midazolam",{"measure":45,"description":46,"timeFrame":12},"Period 1: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)","Blood samples will be collected at multiple time points to determine the Cmax of midazolam metabolite (1-hydroxymidazolam).",{"measure":48,"description":46,"timeFrame":15},"Period 2: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)",{"measure":50,"description":51,"timeFrame":12},"Period 1: Time to Maximum Plasma Concentration (Tmax) of Midazolam","Blood samples will be collected at multiple time points to determine the Tmax of midazolam.",{"measure":53,"description":51,"timeFrame":15},"Period 2: Tmax of Midazolam",{"measure":55,"description":56,"timeFrame":12},"Period 1: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)","Blood samples will be collected at multiple time points to determine the Tmax of midazolam metabolite (1-hydroxymidazolam).",{"measure":58,"description":56,"timeFrame":15},"Period 2: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)",{"measure":60,"description":61,"timeFrame":12},"Period 1: Apparent Terminal Half-life (t1\u002F2) of Midazolam","Blood samples will be collected at multiple time points to determine the t1\u002F2 of midazolam.",{"measure":63,"description":61,"timeFrame":15},"Period 2: t1\u002F2 of Midazolam",{"measure":65,"description":66,"timeFrame":12},"Period 1: t1\u002F2 of Midazolam Metabolite (1-Hydroxymidazolam)","Blood samples will be collected at multiple time points to determine the t1\u002F2 of midazolam metabolite (1-hydroxymidazolam).",{"measure":68,"description":66,"timeFrame":15},"Period 2: t1\u002F2 of Midazolam Metabolite (1-Hydroxymidazolam)",{"measure":70,"description":71,"timeFrame":12},"Period 1: Apparent Clearance (CL\u002FF) of Midazolam","Blood samples will be collected at multiple time points to determine the CL\u002FF of midazolam.",{"measure":73,"description":71,"timeFrame":15},"Period 2: CL\u002FF of Midazolam",{"measure":75,"description":76,"timeFrame":12},"Period 1: Apparent Volume of Distribution During Terminal Phase (Vz\u002FF) of Midazolam","Blood samples will be collected at multiple time points to determine the Vz\u002FF of midazolam.",{"measure":78,"description":76,"timeFrame":15},"Period 2: Vz\u002FF of Midazolam",{"measure":80,"description":81,"timeFrame":19},"Period 1: AUC0-last of Rosuvastatin","Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin.",{"measure":83,"description":81,"timeFrame":22},"Period 2: AUC0-last of Rosuvastatin",{"measure":85,"description":86,"timeFrame":19},"Period 1: Cmax of Rosuvastatin","Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin.",{"measure":88,"description":86,"timeFrame":22},"Period 2: Cmax of Rosuvastatin",{"measure":90,"description":91,"timeFrame":19},"Period 1: Tmax of Rosuvastatin","Blood samples will be collected at multiple time points to determine the Tmax of rosuvastatin.",{"measure":93,"description":91,"timeFrame":22},"Period 2: Tmax of Rosuvastatin",{"measure":95,"description":96,"timeFrame":19},"Period 1: t1\u002F2 of Rosuvastatin","Blood samples will be collected at multiple time points to determine the t1\u002F2 of rosuvastatin.",{"measure":98,"description":96,"timeFrame":22},"Period 2: t1\u002F2 of Rosuvastatin",{"measure":100,"description":101,"timeFrame":19},"Period 1: CL\u002FF of Rosuvastatin","Blood samples will be collected at multiple time points to determine the CL\u002FF of rosuvastatin.",{"measure":103,"description":101,"timeFrame":22},"Period 2: CL\u002FF of Rosuvastatin",{"measure":105,"description":106,"timeFrame":19},"Period 1: Vz\u002FF of Rosuvastatin","Blood samples will be collected at multiple time points to determine the Vz\u002FF of rosuvastatin.",{"measure":108,"description":106,"timeFrame":22},"Period 2: Vz\u002FF of Rosuvastatin",{"measure":110,"description":111,"timeFrame":112},"Number of Participants Who Experience One or More Adverse Events (AEs)","An AE is 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. The number of participants who experience one or more AEs will be reported.","Up to approximately 2 months",{"measure":114,"description":115,"timeFrame":116},"Number of Participants Who Discontinue Study Drug Due to an AE","An AE is 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. The number of participants who discontinue study treatment due to an AE will be reported.","Up to approximately 23 days",{"measure":118,"description":119,"timeFrame":120},"Period 2 Day 1: Plasma Concentration at 12 Hours (C12) of MK-6916","Blood samples will be collected at multiple time points to determine the C12 of MK-6916.","Day 1: predose and at designated timepoints up to approximately 12 hours post dose",{"measure":122,"description":123,"timeFrame":120},"Period 2 Day 1: C12 of MK-6916 Metabolite (M5)","Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M5).",{"measure":125,"description":126,"timeFrame":120},"Period 2 Day 1: C12 of MK-6916 Metabolite (M9)","Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M9).",{"measure":128,"description":119,"timeFrame":129},"Period 2 Day 14: C12 of MK-6916","Day 14: predose and at designated timepoints up to approximately 12 hours post dose",{"measure":131,"description":123,"timeFrame":129},"Period 2 Day 14: C12 of MK-6916 Metabolite (M5)",{"measure":133,"description":126,"timeFrame":129},"Period 2 Day 14: C12 of MK-6916 Metabolite (M9)",null,{"allocation":136,"interventionModel":137,"interventionModelDescription":134,"primaryPurpose":138,"observationalModel":134,"timePerspective":134,"maskingInfo":139},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":140,"maskingDescription":134,"whoMasked":134},"NONE",[142],{"label":143,"type":144,"description":145,"interventionNames":146},"Midazolam + Rosuvastatin + MK-6916","EXPERIMENTAL","In Period 1, participants will receive midazolam and rosuvastatin. In Period 2, participants will receive MK-6916, midazolam, and rosuvastatin.",[147,148,149],"Drug: Midazolam","Drug: Rosuvastatin","Drug: MK-6916",[151,156,160],{"type":152,"name":153,"description":154,"armGroupLabels":155,"otherNames":134},"DRUG","Midazolam","Administered orally on Day 1 of Period 1 and on Days 2 and 14 of Period 2.",[143],{"type":152,"name":157,"description":158,"armGroupLabels":159,"otherNames":134},"Rosuvastatin","Administered orally on Day 1 of Period 1 and Day 14 of Period 2.",[143],{"type":152,"name":161,"description":162,"armGroupLabels":163,"otherNames":134},"MK-6916","Administered orally once every 12 hours on Days 1 through 18 in Period 2.",[143],[165],{"name":166,"affiliation":5,"role":167},"Medical Director","STUDY_DIRECTOR",{"type":169,"investigatorFullName":134,"investigatorTitle":134,"investigatorAffiliation":134,"oldNameTitle":134,"oldOrganization":134},"SPONSOR","100659347","phase-1-a-clinical-trial-of-mk-6916-with-midazolam-and-rosuvastatin-in-healthy-participants-mk-6916-012-100659347",false,"NCT07862621","A Clinical Trial of MK-6916 With Midazolam and Rosuvastatin in Healthy Participants (MK-6916-012)","A 2-period Study to Evaluate the Effects of Multiple Oral Doses of MK-6916 on the Single-dose Pharmacokinetics of Midazolam and Rosuvastatin","Inclusion Criteria:\n\n* Is in good health\n* Has a body mass index between 18 and 32 kg\u002Fm\\^2, inclusive\n\nExclusion Criteria:\n\n* Has history of cancer (malignancy)\n* Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus",true,"ALL","18 Years","55 Years",{"count":182,"type":183},18,"ESTIMATED","INTERVENTIONAL",[186],"PHASE1","Researchers are looking for new treatments for pain. The goal of this trial is to learn if MK-6916 changes what happens to the midazolam and rosuvastatin in healthy participants' bodies. Researchers will compare the amount of midazolam and rosuvastatin in a participant's body over time when they are given with and without MK-6916.",[189],"Healthy","NOT_YET_RECRUITING","2026-10-02",{"date":193,"type":194},"2026-10-07","ACTUAL",{"date":196,"type":183},"2026-11-30",{"date":198,"type":183},"2027-02-19",{"name":5,"class":6}]