NCT00882557已完成1 期
A Prospective, Randomized, Crossover-design Study to Evaluate the Pharmacokinetics and Safety of Daptomycin Administered at 9 mg/kg During and 6 mg/kg After Hemodialysis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年4月29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
- 16
- 试验地点
- 2
- 主要终点
- Evaluation of Area Under the Curve From Time 0 to Infinity
研究概览
简要总结
The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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;
- •Male or female ≥ 18 years of age;
- •If female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration;
- •End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes;
- •Functioning hemodialysis access (for example, graft or fistula);
- •Considered to be in appropriate health for study entry by the Investigator (for example, no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
- •If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study drug administration.
排除标准
- •Received an investigational drug (including experimental biologic agents) within 30 days of study drug administration;
- •Has received any dose of daptomycin within 7 days prior to study drug administration;
- •Known to be allergic or intolerant to daptomycin;
- •Evidence of active ongoing infection;
- •Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;
- •Active illicit drug use or alcohol abuse;
- •Myocardial infarction within last 6 months;
- •Subject with a history of muscular disease (for example, polymyositis, muscular dystrophy);
- •Subject with a history of neurological disease (for example, Guillain Barré, multiple sclerosis), except stroke > 6 months prior to study entry;
- •Intramuscular injection within 7 days of study drug administration;
- •Body mass index (BMI) ≤ 18.5 or ≥ 40 kg/m2 (BMI = weight [kg]/height [m2]);
- •WBC ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3;
- •Neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3;
- •Baseline CPK values ≥ 3X ULN (upper limit of normal);
- •Alanine aminotransferase (ALT) > 5XULN;
- •Aspartate aminotransferase (AST) > 5XULN;
- •Hemoglobin ≤ 9 gm/dL;
- •Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
- •History of rhabdomyolysis.
研究组 & 干预措施
A
Experimental
9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.
干预措施: daptomycin (Drug)
B
Experimental
Post dialysis dosing
干预措施: daptomycin (Drug)
结局指标
主要结局
Evaluation of Area Under the Curve From Time 0 to Infinity
时间窗: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)
Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses
次要结局
- Treatment-emergent Adverse Events(Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).)
研究者
研究点 (2)
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