[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100218009":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":28,"centralContacts":27,"locations":27,"responsibleParty":33,"collaborators":35,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":27,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":27,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":27,"overallStatus":58,"whyStopped":27,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":27},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Ertugliflozin 15 mg - Moderate Hepatic Impairment","EXPERIMENTAL","Participants receive a single 15 mg oral dose (tablet) of ertugliflozin",[13],"Drug: Ertugliflozin 15 mg",{"label":15,"type":16,"description":11,"interventionNames":17},"Ertugliflozin 15 mg - Healthy Participants","OTHER",[13],{"label":19,"type":10,"description":11,"interventionNames":20},"Ertugliflozin 15 mg - Mild Hepatic Impairment",[13],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Ertugliflozin 15 mg","Tablet",[15,19,9],null,[29],{"name":30,"affiliation":31,"role":32},"Medical Director","Merck\u002FPfizer","STUDY_DIRECTOR",{"type":34,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[36],{"name":37,"class":6},"Pfizer","100218009","phase-1-pharmacokinetics-safety-and-tolerability-of-ertugliflozin-mk-8835pf-04971729-in-participants-with-hepatic-impairment-and-in-healthy-participants-mk-8835-014-100218009",true,"NCT02115347","Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835\u002FPF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)","A Phase 1, Non-randomized, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Ertugliflozin (MK-8835\u002FPF-04971729) in Subjects With Hepatic Impairment and the Healthy Subjects With Normal Hepatic Function","Inclusion Criteria:\n\nALL PARTICIPANTS:\n\n* Body Mass Index (BMI) of 18 to 40 kg\u002Fm\\^2; and a total body weight \\>50 kg (110 lbs)\n* Male or female not of reproductive potential\n* If a female of reproductive potential, agrees to remain abstinent from heterosexual activity or agree to use or have their partner use 2 methods of acceptable contraception to prevent pregnancy while the participant is receiving study medication and for 14 days after the last dose of study medication PARTICIPANTS WITH NORMAL HEPATIC FUNCTION\n* Healthy with normal hepatic function PARTICIPANTS WITH HEPATIC IMPAIRMENT\n* Satisfy the criteria for Child-Pugh classification \\[moderate (Part 1): Child-Pugh Scores 7-9 points, mild (Part 2): Child-Pugh Scores 5-6 points\\] within 14 days before administration of study medication\n* A diagnosis of hepatic impairment due to primary liver disease and not secondary to other diseases\n* Stable hepatic impairment, defined as no clinically-significant change in disease status within the last 30 days\n* On a stable dose of medication and\u002For treatment regimen used to manage hepatic disease for at least 4 weeks prior to study start\n\nExclusion Criteria:\n\nALL PARTICIPANTS\n\n* A known hypersensitivity or intolerance to ertugliflozin or any other Sodium-Glucose co-Transporter 2 (SGLT2) inhibitor (i.e., canagliflozin \\[Invokana\\], dapagliflozin \\[Farxiga\\], empagliflozin, or ipragliflozin)\n* Febrile illness within 5 days prior to the first dose of study medication\n* Any clinically significant malabsorption condition\n* A positive urine drug screen for drugs of abuse or recreational drugs\n* Abuse of alcohol or binge drinking and\u002For any other illicit drug use or dependence within 6 months of study start\n* Treatment with an investigational drug within 30 days preceding the first dose of study medication\n* Pregnant or breastfeeding females\n* Use of herbal supplements within 28 days prior to the first dose of study medication\n* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing\n* History of sensitivity to heparin or heparin-induced thrombocytopenia PARTICIPANTS WITH NORMAL HEPATIC FUNCTION\n* Use of prescription drugs (hormonal methods of birth control are allowed), vitamins, and dietary supplements within 7 days prior to the first dose of study medication\n* Positive serology for Hepatitis B or C PARTICIPANTS WITH HEPATIC IMPAIRMENT\n* Hepatic carcinoma and hepatorenal syndrome or life expectancy less than 1 year\n* Undergone portal-caval shunt surgery\n* History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry\n* Signs of significant hepatic encephalopathy\n* Severe ascites and\u002For pleural effusion\n* A transplanted kidney, heart or liver\n* Received any of the following medications within 7 days prior to the first dose of study medication or during the study: other SGLT2 inhibitors (eg, dapagliflozin, canagliflozin, empagliflozin, and ipragliflozin); any potent drug-metabolizing enzyme-inducing drug, including rifampin, phenytoin, and carbamazepine; probenecid, valproic acid, gemfibrozil","ALL","18 Years","75 Years",{"count":49,"type":50},16,"ACTUAL","INTERVENTIONAL",[53],"PHASE1","This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1 of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).",[56,57],"Type 2 Diabetes Mellitus","Hepatic Impairment","COMPLETED","2018-08-17",{"date":61,"type":50},"2018-08-20",{"date":63,"type":50},"2014-09-19",{"date":65,"type":50},"2015-01-19",{"name":5,"class":6}]