A Study to Evaluate Safety and Tolerability of Co-administration of MK-2060 and Clopidogrel in Participants With End-Stage Renal Disease on Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)
研究概览
简要总结
MK-2060 is being developed for prevention of thrombotic complications in end-stage renal disease (ESRD). The purpose of this study is to conduct a preliminary evaluation of the safety and tolerability of MK-2060 treatment in combination with a commonly used P2Y12 receptor inhibitor, clopidogrel, in ESRD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has End-Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen at a healthcare center for > 3 months prior to dosing.
- •On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft.
- •Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.
- •Has a Body Mass Index (BMI) ≥ 18 and ≤ 45 kg/m^2.
排除标准
- •History of cancer (malignancy), including adenocarcinoma, except adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up.
- •Has a history of deep vein thrombosis or pulmonary embolism.
- •Has a history of gastrointestinal (GI) bleeding, duodenal polyps or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in last 3 months prior to screening.
- •Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
- •Has ongoing anticoagulant therapy or antiplatelet therapy, not including clopidogrel. Intradialytic heparin is permitted.
研究组 & 干预措施
MK-2060
Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). Participants then continued background therapy while receiving 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8.
干预措施: MK-2060 (Drug)
结局指标
主要结局
Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)
时间窗: Up to approximately 104 days
Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically-relevant non major bleeding or major bleeding.
Number of Participants Who Experience One or More AEs
时间窗: Up to approximately 104 days
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Intervention Due to an AE
时间窗: Up to approximately 8 days
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
次要结局
- Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) of MK-2060(Day 1: predose, and 1, 12, 24, and 48 hours postdose. Day 8: predose, and 1, 12, 24, 48, 96, and 168 hours postdose.)
- Maximum Plasma Concentration (Cmax) of MK-2060(Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.)
- Plasma Concentration at 168 Hours (C168) of MK-2060(Days 1 and 8: 168 hours post-dose)
- Time to Maximum Plasma Concentration (Tmax) of MK-2060(Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.)
- Terminal Half Life (t1/2) of MK-2060(Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.)
- Clearance at Steady State (CLss) of MK-2060(Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.)
- Apparent Volume of Distribution at Steady State (Vss) of MK-2060(Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.)
- Time to Hemostasis Following MK-2060 Treatment(Up to approximately 15 days)