[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100309706":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":53,"centralContacts":40,"locations":57,"responsibleParty":80,"collaborators":40,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":40,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":40,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":40,"overallStatus":101,"whyStopped":40,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16,21,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"End Stage Renal Disease","EXPERIMENTAL","Participants requiring hemodialysis. Period 1\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). A washout period of at least 14 days will separate dosings.",[13,14,15],"Drug: Midazolam oral solution","Drug: Dabigatran and pitavastatin oral solution","Drug: Atorvastatin and rosuvastatin oral solution",{"label":17,"type":10,"description":18,"interventionNames":19},"Severe Impairment","Participants with \\\u003C30 mL\u002Fmin\u002F1.73m\\^2 estimated glomerular filtration rate (eGFR) not on hemodialysis. Period 1\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.",[13,14,15,20],"Drug: Rifampin",{"label":22,"type":10,"description":23,"interventionNames":24},"Moderate Impairment","Participants with 30 to \\\u003C60 mL\u002Fmin\u002F1.73m\\^2 eGFR not on hemodialysis. Period 1\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.",[13,14,15,20],{"label":26,"type":10,"description":27,"interventionNames":28},"Mild Impairment","Participants with 60 to \\\u003C90 mL\u002Fmin\u002F1.73m\\^2 eGFR not on hemodialysis. Period 1\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.",[13,14,15,20],{"label":30,"type":31,"description":32,"interventionNames":33},"Healthy Control","ACTIVE_COMPARATOR","Participants with ≥90 mL\u002Fmin creatinine clearance. Period 1\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution). Period 2\u002FDay 1: participants receive a single oral dose of the microdose cocktail (midazolam oral solution, dabigatran etexilate and pitavastatin oral solution, atorvastatin and rosuvastatin oral solution) and rifampin. A washout period of at least 14 days will separate dosings.",[13,14,15,20],[35,41,45,49],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Midazolam oral solution","Midazolam hydrochloride 10 μg (1 mL of 10 μg\u002FmL oral solution), administered orally as part of a microdose cocktail",[9,30,26,22,17],null,{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"Dabigatran and pitavastatin oral solution","375\u002F10 μg dabigatran etexilate and pitavastatin (1 mL of 375\u002F10 μg\u002FmL oral solution), administered orally as part of a microdose cocktail",[9,30,26,22,17],{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":40},"Atorvastatin and rosuvastatin oral solution","100\u002F50 μg atorvastatin and rosuvastatin (2 mL of 50\u002F25 μg\u002FmL oral solution), administered orally as part of a microdose cocktail",[9,30,26,22,17],{"type":36,"name":50,"description":51,"armGroupLabels":52,"otherNames":40},"Rifampin","Rifampin 600 mg single dose (two 300 mg capsules) administered orally",[30,26,22,17],[54],{"name":55,"affiliation":5,"role":56},"Medical Director","STUDY_DIRECTOR",[58,71],{"facility":59,"status":40,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":40},"Clinical Pharmacology of Miami ( Site 0001)","Hialeah","Florida","33014","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-80.27811,25.8576,{"lat":69,"lon":68},{"facility":72,"status":40,"city":73,"state":61,"zip":74,"country":63,"countryCode":64,"cosmosGeoPoint":75,"geoPoint":79,"contacts":40},"Orlando Clinical Research Center ( Site 0002)","Orlando","32809",{"type":66,"coordinates":76},[77,78],-81.37924,28.53834,{"lat":78,"lon":77},{"type":81,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100309706","phase-1-pharmacokinetics-of-midazolam-dabigatran-pitavastatin-atorvastatin-and-rosuvastatin-in-participants-with-renal-insufficiency-in-the-presence-and-absence-of-rifampin-mk-0000-386-100309706",true,"NCT03311841","Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)","A Study to Assess the Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin Administered as Microdoses in Subjects With Varying Degrees of Renal Insufficiency in the Presence and Absence of Rifampin","Inclusion Criteria:\n\nAll participants (with mild, moderate or severe renal impairment, end stage renal disease, or healthy):\n\n* a female must be non-pregnant, non-breast feeding and if she is of reproductive potential: must agree to use (and\u002For have their partner use) two acceptable methods of birth control beginning at screening, throughout the study and until 2 weeks after the last dosing of study drug\n* a female of non-childbearing potential: must have undergone a sterilization procedure at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose\n* a non-vasectomized male participant must agree to use a condom with spermicide or abstain from sexual intercourse from the first dose until 90 days after the last dose of study drug\n* a male participant must agree not to donate sperm from dosing until 90 days after the last dose of study drug\n* has a body mass index (BMI) ≤ 40.0 kg\u002Fm\\^2\n* is a non-smoker or moderate smoker (≤ 20 cigarettes\u002Fday or the equivalent)\n\nParticipants with mild, moderate or severe renal impairment or end stage renal disease:\n\n* has a clinical diagnosis of renal impairment and meets the protocol-specified renal impairment function qualifications at the prestudy visit (screening)\n\nHealthy participants:\n\n* has baseline creatinine clearance ≥ 90 mL\u002Fmin based on Cockcroft-Gault equation\n* is judged to be in good health based on medical history, physical examination, vital signs, pulse oximetry, and laboratory safety tests\n\nExclusion Criteria:\n\nAll participants (with mild, moderate or severe renal impairment, end stage renal disease, or healthy):\n\n* is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n* history or presence of clinically significant medical or psychiatric condition or disease\n* history of stroke, chronic seizures, or major neurological disorders\n* history of malignant neoplastic disease\n* history or presence of alcoholism or drug abuse within the past 6 months\n* female participant who is pregnant or lactating\n\nParticipants with mild, moderate or severe renal impairment:\n\n* has had a renal transplant or has had nephrectomy\n* has uncontrolled type 2 diabetes mellitus (T2DM), a history of Type 1 diabetes, or ketoacidosis\n* history of significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases\n\nParticipants with end stage renal disease (ESRD):\n\n* had a failed renal allograft within the last 2 years prior to the first dose, or a successful renal allograft\n* has uncontrolled T2DM, a history of Type 1 diabetes, or ketoacidosis\n* history of significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases\n\nHealthy participants:\n\n* history of hypoglycemia, glucose intolerance, T2DM, or ketoacidosis\n* history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.","ALL","18 Years","78 Years",{"count":93,"type":94},32,"ACTUAL","INTERVENTIONAL",[97],"PHASE1","The purpose of this open-label, 2-period, fixed-sequence study is to characterize the plasma pharmacokinetic profiles of midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin following a single oral dose administration of a microdose cocktail in healthy participants, in participants with mild, moderate, severe (not on dialysis) renal impairment, and in participants with end-stage renal disease (ESRD; on dialysis).",[100],"Renal Insufficiency","COMPLETED","2019-12-19",{"date":104,"type":94},"2020-01-09",{"date":106,"type":94},"2018-03-01",{"date":108,"type":94},"2018-08-02",{"name":5,"class":6},2]