NCT00490737已完成1 期
An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 个研究点目标入组 12 人开始时间: 2007年8月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
详细描述
This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin. Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to any study-related procedure not part of normal medical care;
- •Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
- •Male or female >18 years of age;
- •If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for >28 days after study completion;
- •If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration;
- •Functioning dialysis access (e.g. graft or fistula) for subjects undergoing HD and functioning dialysis access (e.g. peritoneal catheter) for subjects undergoing CAPD;
- •ESRD on stable HD regimen of thrice weekly sessions with high-flux membranes or stable CAPD regimen.
排除标准
- •If female, pregnant or lactating;
- •Received an investigational drug (including experimental biologic agents) within 30 days of study entry;
- •Evidence of active ongoing infection;
- •Unable to discontinue use of HMG-CoA reductase inhibitor therapy for duration of study;
- •Has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug;
- •Known to be allergic or intolerant to daptomycin;
- •Body Mass Index (BMI) < 18.5 or > 40 kg/m2 [BMI = weight (kg)/height (m2)];
- •WBC >12, 000 cells/mm3 or <2500 cells/ mm3;
- •Baseline creatinine phosphokinase (CPK) values >3X ULN (upper limit of normal);
- •Alanine aminotransferase (ALT) >5X ULN;
- •Aspartate aminotransferase (AST) >5X ULN;
- •Known HIV-infected subjects with CD4 count ≤200 cells/mm3;
- •Hemoglobin < 9 gm/dL;
- •Active illicit drug and/or alcohol abuse;
- •Myocardial infarction within last 6 months;
- •Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days;
- •Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy);
- •Subjects with a history of neurological disease (e.g., Guillain Barré, multiple sclerosis), except stroke >6 months prior to study entry;
- •Intramuscular injection within 7 days of study drug administration;
- •Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days);
- •Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
- •Neutropenic subjects with absolute neutrophil count ≤500 cells/mm3 History of rhabdomyolysis.
研究组 & 干预措施
Hemodialysis (HD) Participants
Experimental
Participants will receive daptomycin 6 mg/kg by intravenous infusion (i.v.) at 48-hours intervals (with dialysis) for a total of 3 doses.
干预措施: daptomycin (Drug)
Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants
Experimental
Participants will receive daptomycin 6 mg/kg, i.v., at 48-hours intervals for a total of 3 doses.
干预措施: daptomycin (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: Study Day 1, 3, 5 and 7 or 8
次要结局
- Safety and Tolerability(Study Days 1 through 16 or 17)
研究者
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