A Single Dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Serelaxin in Patients With Severe Renal Impairment or End-Stage Renal Disease on Hemodialysis Compared to Matched Healthy Control Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The observed maximum serum concentration following drug administration (Cmax)
研究概览
简要总结
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •All subjects
- •History of clinically significant ECG abnormalities at Screening or Baseline.
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential unless they are using highly effective methods of contraception during dosing of study treatment.
- •Sexually active males (incl. vasectomized men) must use a condom during intercourse while taking drug and for 2 weeks after stopping study medication.
- •Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
- •Patients with severe renal impairment / ESRD:
- •Presence of any non-controlled and clinically significant disease, surgical or medical condition that could affect the study outcome or that would place the patient at undue risk as judged by the investigator.
- •Hemoglobin levels below 9.0 g/dL at screening and baseline, other laboratory parameters at screening and baseline outside acceptable limits .
- •Treatment with any cytostatic drug or autonomic alpha blocker.
- •Healthy subjects:
- •Use of any prescription drugs (other than hormonal contraception, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- •History or presence of any disease, surgical or medical condition of any major system organ class considered clinically significant by the investigator.
- •Laboratory parameter at screening and baseline outside of normal limits. For small deviations which could be attributed to the characteristics of the subjects (e.g. age) it will be to the discretion of the investigator to consider them as exclusive or not.
- •A positive Hepatitis B surface antigen or Hepatitis C test result.
研究组 & 干预措施
Group 1 Treatment with serelaxin
Patients with severe renal impairment will receive a single 4 hour i.v. infusion of serelaxin
干预措施: Serelaxin (Drug)
Group 2 Treatment with serelaxin
Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment
干预措施: Serelaxin (Drug)
Group 3 Treatment with serelaxin
Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and treatment and PK will be done in dialysis-free interval
干预措施: Serelaxin (Drug)
Group 4 Treatment with serelaxin
Healthy volunteers will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment
干预措施: Serelaxin (Drug)
结局指标
主要结局
The observed maximum serum concentration following drug administration (Cmax)
时间窗: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
The area under the serum concentration-time curve from time zero to 28 hours after administration (AUC 0-28hr)
时间窗: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
时间窗: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
The area under the serum concentration-time curve from time zero to infinity (AUCinf)
时间窗: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
次要结局
- Percentage of patients developing anti-RLX030 antibodies(Day 1 (pre-treatment) and Day 15)
- Percentage of patients with reported adverse events, serious adverse events and death.(From Day -21 to Day 15)