A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Vepoloxamer in Subjects With Varying Degrees of Renal Impairment and Healthy Matched Control Subjects With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Pharmacokinetics variable - Area under the plasma concentration curve
研究概览
简要总结
This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2
- •Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days
- •If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration
- •If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration
- •Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results
- •Non-smoker, or smokes fewer than 10 cigarettes/day
- •Key Exclusion Criteria
- •Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator
- •Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration
- •Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening
- •Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1
- •Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration
排除标准
- 未提供
研究组 & 干预措施
Cohort 1: Normal Renal Function
Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours
干预措施: Vepoloxamer (Drug)
Cohort 2: Mild Renal Impairment
Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours
干预措施: Vepoloxamer (Drug)
Cohort 3: Moderate Renal Impairment
Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours
干预措施: Vepoloxamer (Drug)
Cohort 4: Severe Renal Impairment
Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours
干预措施: Vepoloxamer (Drug)
Cohort 5: End Stage Renal Disease
Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours
干预措施: Vepoloxamer (Drug)
结局指标
主要结局
Pharmacokinetics variable - Area under the plasma concentration curve
时间窗: Time zero through 96 hours
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03(Time zero through Day 14)