[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205284":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":38,"centralContacts":42,"locations":42,"responsibleParty":43,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":42,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":42,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":42,"overallStatus":68,"whyStopped":42,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":42},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Ertugliflozin 15 mg (T2DM with Normal Renal Function)","EXPERIMENTAL","Ertugliflozin (15 mg), oral, administered in participants with T2DM and with normal renal function",[13],"Drug: Ertugliflozin",{"label":15,"type":10,"description":16,"interventionNames":17},"Ertugliflozin 15 mg (T2DM with Mild Renal Impairment)","Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Ertugliflozin 15 mg (T2DM with Moderate Renal Impairment)","Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Ertugliflozin 15 mg (T2DM with Severe Renal Impairment)","Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Ertugliflozin, 15 mg (Healthy Part. with Normal Renal Funct.)","Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Ertugliflozin","Single oral administration of 3 X 5 mg tablets.",[15,19,9,23,27],[37],"MK-8835",[39],{"name":40,"affiliation":5,"role":41},"Medical Director","STUDY_DIRECTOR",null,{"type":44,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[46],{"name":47,"class":6},"Pfizer","100205284","phase-1-effect-of-renal-impairment-on-the-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-ertugliflozin-in-participants-with-type-2-diabetes-mellitus-mk-8835-009-100205284",true,"NCT01948986","Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)","A Phase 1, Non-Randomized, Open-Label, Single Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Subjects With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Body Mass Index (BMI) of approximately 18 to 40 kg\u002Fm\\^2\n* Stable renal function\n* Male or female not of reproductive potential\n* Female of reproductive potential must agree or have their partner agree to use 2 acceptable methods of contraception\n* Healthy subjects determined to be healthy by investigator screening\n* T2DM participants have a diagnosis of T2DM as per American Diabetes Association guidelines\n* T2DM participants to be on a stable anti-hyperglycemic regimen with no new drug or drug dosage within 8 weeks of study participation. Variations in daily dose of insulin up to 10% are permitted.\n\nExclusion Criteria:\n\n* A positive urine drug screen for drugs of abuse or recreational drugs\n* Pregnant or nursing females\n* History of abuse of alcohol or illicit drugs\n* Significant renal or urinary disease within 6 months of study participation\n* History of malignancy within the past 5 years basal cell carcinoma of the skin or cervical cancer in situ\n* History of human immunodeficiency virus (HIV)\n* History of blood dyscrasias or any disorders causing hemolysis or unstable red blood cells\n* Any acute disease state (eg, , vomiting, fever, diarrhea) within 7 days before study participation\n* Treatment with an investigational drug within 30 days of study participation\n* Use of herbal supplements within 28 days prior to study participation\n* Any clinically significant malabsorption condition\n* Blood donation (excluding plasma donations) of approximately 1 pint within 56 days prior to study participation\n* History of sensitivity to ertugliflozin or other Sodium-Glucose co-Transporter 2 (SGLT2) inhibitors\n* History of sensitivity to heparin or heparin-induced thrombocytopenia\n* Unwilling or unable to comply with the study Lifestyle Guidelines\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease including clinically relevant and significant drug allergies\n* Use of prescription drugs (hormonal methods of birth control are allowed), vitamins and dietary supplements within 7 days of study participation\n* For T2DM participants, history of type 1 diabetes mellitus or a history of ketoacidosis\n* For T2DM participants, clinically significant electrocardiogram abnormality\n* For T2DM participants, history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack within 3 months of study participation\n* For T2DM participants, heart failure defined as New York Heart Association Functional Class III-IV\n* For T2DM participants, renal allograft recipients\n* For T2DM participants, requiring dialysis\n* For T2DM participants, strict fluid restriction\n* For T2DM participants, urinary incontinence\n* For T2DM participants, acute renal disease\n* For T2DM participants, significant hepatic, cardiac, or pulmonary disease or clinically nephrotic\n* For T2DM participants, prescription and over-the-counter medication that is not taken according to a stable regimen for 7 days before study participation\n* For T2DM participants, on metformin should not be enrolled if their baseline renal function is outside the approved product labeling\n* For T2DM participants receiving any of the following medications within 7 days of study participation: 1. Other SGLT2 inhibitors (eg, dapagliflozin, canagliflozin, empagliflozin); 2. Other injectable anti-hyperglycemic agents including pramlintide or Glucagon-like peptide-1 (GLP-1) analogues; 3. Any immunosuppressive drugs, including cyclosporine, tacrolimus, sirolimus; 4. Oral corticosteroids (note that inhaled, nasal and topical corticosteroids are permitted); 5. Any potent drug-metabolizing enzyme-inducing drug, including rifampin, phenytoin, and carbamazepine; 6. Probenecid, valproic acid, gemfibrozil.","ALL","18 Years","80 Years",{"count":59,"type":60},36,"ACTUAL","INTERVENTIONAL",[63],"PHASE1","This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with normal renal function.",[66,67],"Renal Impairment","Type 2 Diabetes Mellitus","COMPLETED","2018-10-11",{"date":71,"type":60},"2019-02-18",{"date":73,"type":60},"2013-10-01",{"date":75,"type":60},"2014-10-16",{"name":5,"class":6}]