[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100229833":3},{"organization":4,"armGroups":7,"interventions":58,"overallOfficials":82,"centralContacts":64,"locations":64,"responsibleParty":86,"collaborators":64,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":64,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":64,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":64,"overallStatus":108,"whyStopped":64,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":64},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16,20,24,28,32,36,40,46,50,54],{"label":9,"type":10,"description":11,"interventionNames":12},"Part I: MK-2640 (Panel A)","EXPERIMENTAL","Part I: Lowest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours.",[13,14,15],"Drug: MK-2640","Drug: Dextrose","Drug: Rescue medication",{"label":17,"type":10,"description":18,"interventionNames":19},"Part I: MK-2640 (Panel B)","Part I: Low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Part I: MK-2640 (Panel C)","Part I: Medium-low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Part I: MK-2640 (Panel D)","Part I: Medium dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours.",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"Part I: MK-2640 (Panel E)","Part I: Medium-high dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours.",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"Part I: MK-2640 (Panel F)","Part I: High dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours.",[13,14,15],{"label":37,"type":10,"description":38,"interventionNames":39},"Part I: MK-2640 (Panel G)","Part 1: Highest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours.",[13,14,15],{"label":41,"type":10,"description":42,"interventionNames":43},"Part II: MK-2640 followed by RHI","Part II: MK-2640 infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II.",[13,44,14,45,15],"Biological: Regular Human Insulin (RHI)","Biological: Insulin aspart",{"label":47,"type":10,"description":48,"interventionNames":49},"Part II: RHI followed by MK-2640","Part II: RHI infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II.",[13,44,14,45,15],{"label":51,"type":10,"description":52,"interventionNames":53},"Part III: MK-2640 followed by RHI","Part III: MK-2640 infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III.",[13,44,14,45,15],{"label":55,"type":10,"description":56,"interventionNames":57},"Part III: RHI followed by MK-2640","Part III: RHI infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III.",[13,44,14,45,15],[59,65,70,74,78],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DRUG","MK-2640","MK-2640 intravenous infusion administered to participant in a fasted state",[9,17,21,25,29,33,37,41,47,51,55],null,{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":64},"BIOLOGICAL","Regular Human Insulin (RHI)","RHI 100 units\u002FmL intravenous infusion to maintain target glycemic level",[41,47,51,55],{"type":60,"name":71,"description":72,"armGroupLabels":73,"otherNames":64},"Dextrose","Dextrose 20% or 50% intravenous infusion for approximately 9 or 7 hours, as appropriate to attain a target glycemic level",[9,17,21,25,29,33,37,41,47,51,55],{"type":66,"name":75,"description":76,"armGroupLabels":77,"otherNames":64},"Insulin aspart","Insulin aspart subcutaneous injection or intravenous infusion the evening before each period in Parts II and III to achieve\u002Fmaintain glycemic target.",[41,47,51,55],{"type":60,"name":79,"description":80,"armGroupLabels":81,"otherNames":64},"Rescue medication","Rescue medication may be administered for hypotension or mild to moderate infusion reaction. Rescue medication may include epinephrine, antihistamines, steroids, or acetaminophen\u002Fparacetamol.",[9,17,21,25,29,33,37,41,47,51,55],[83],{"name":84,"affiliation":5,"role":85},"Medical Director","STUDY_DIRECTOR",{"type":87,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100229833","phase-1-a-three-part-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-mk-2640-in-healthy-participants-part-i-and-participants-with-type-1-diabetes-mellitus-parts-ii-and-iii-mk-2640-001-100229833",false,"NCT02269735","A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)","A Three-part Study Parts I, II and III: Rising Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Subjects (Part I) and Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Subjects With Type 1 Diabetes Mellitus (Part II and Part III).","Inclusion Criteria (Part I):\n\n* healthy male or healthy female of non-child bearing potential\n* in good health\n* is a non-smoker and\u002For has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months\n\nInclusion Criteria (Parts II and III):\n\n* male or female of non-child bearing potential\n* has T1DM for at least 12 months\n* on stable doses of insulin\n* in good health\n* is a nonsmoker and\u002For has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months\n\nExclusion Criteria:\n\n* is mentally or legally incapacitated, or has significant emotional problems at the time of screening visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years\n* has a history of clinically significant endocrine (except T1DM for Part II subjects), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)\n* has a history of cancer (malignancy), except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix\n* has a history of significant multiple and\u002For severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food, had major surgery, donated or lost 1 unit of blood within 4 weeks prior to the screening visit\n* has participated in another investigational trial within 4 weeks prior to the screening visit\n* is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of trial drug, throughout the trial, until the posttrial visit\n* consumes greater than 3 glasses of alcoholic beverages daily\n* consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day.\n* is currently a regular or recreational user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months\n\nExclusion Criteria (Parts II and III):\n\n* has a history of diabetic ketoacidosis in the last 6 months.\n* has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 2 weeks prior to dosing\n* has used systemic (intravenous, oral, inhaled) glucocorticoids within 3 months of screening or is anticipated to require treatment with systemic glucocorticoids during study participation\n* has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in regular human insulin, or to any E. coli-derived drug product",true,"ALL","18 Years","55 Years",{"count":100,"type":101},74,"ACTUAL","INTERVENTIONAL",[104],"PHASE1","The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI), and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I general safety, tolerability and other observed data are supportive of progression to Part II. Part III will be initiated only if Parts I and II general safety, tolerability and other observed data are supportive of progression to Part III.",[107],"Type 1 Diabetes Mellitus","COMPLETED","2019-01-11",{"date":111,"type":101},"2019-01-15",{"date":113,"type":101},"2014-11-26",{"date":115,"type":101},"2016-07-29",{"name":5,"class":6}]