A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2060 in Japanese Older Participants With End-stage Renal Disease on Dialysis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 12
- 主要终点
- Number of Participants Who Experienced an Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Japanese descent with all 2 biological parents of Japanese descent
- •On hemodialysis (HD) or hemodiafiltration (HDF) with single-pool Kt/V (spKt/V) ≥1.2, using arteriovenous (AV) fistula or AV graft ≥3 months prior to Screening 1 at a healthcare center, and is on the same dialysis regimen ≥2 weeks prior to Screening 1
- •Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •On peritoneal dialysis or other dialysis modalities except for HD and HDF
- •History of deep vein thrombosis or pulmonary embolism
- •History of vascular access thrombosis within 1 month prior to Screening 1
- •Personal or family history of bleeding disorder
- •History of GI bleeding, duodenal polyps or active gastroduodenal ulcer within 5 years prior to Screening 1, or history of severe hemorrhoidal bleed within 3 months prior to Screening 1
- •History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis
- •At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial
- •History of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or a brand of Rho(D) immune globulin (RhoGAM) within 1 year prior to Screening 1
- •History of receiving any biological therapy within 3 months prior to Screening 1, or vaccination within 1 month prior to the dose of study intervention
- •Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs)
- •Participated in another investigational study within 1 month prior to Screening 1
- •Has blood coagulation test (activated partial thromboplastin time [aPTT] or prothrombin time [PT]) above 1.2X upper limit of normal (ULN) at Screening 1 from the central laboratory for safety
研究组 & 干预措施
MK-2060
Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes.
干预措施: MK-2060 (Biological)
Placebo
Participants receive a single IV saline infusion over 60 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: Up to approximately 164 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported.
Number of Participants Who Discontinued Study Due to an AE
时间窗: Up to approximately 164 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported.
次要结局
- Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Terminal Half-Life (t ½) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf)(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168)(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Time to Maximum Concentration (Tmax) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last)(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Maximum Concentration (Cmax) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Clearance (CL) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Volume of Distribution (Vz) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Concentration at 168 Hours (C168) Postdose of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Change From Baseline in Activated Partial Thromboplastin Time (aPTT)(Baseline and 168 hours post dose)