A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF RIVIPANSEL (PF-06460031) IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Clearance (CL)
研究概览
简要总结
The purpose of this study is to determine the effect of renal impairment on rivipansel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Female subjects of non-childbearing potential or male subjects
- •Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
- •Stable renal function
排除标准
- •A positive urine drug screen for illicit drugs
- •Treatment with an investigational drug within 30 days of the dose of study medication
- •Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
- •Use of herbal supplements in the 28 days prior to the dose of study medication
- •Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
- •Requiring dialysis
研究组 & 干预措施
Moderate Renal Impairment
A single dose of IV Rivipansel over 20 minutes
干预措施: Rivipansel (Drug)
Mild Renal Impairment
A single dose of IV Rivipansel over 20 minutes
干预措施: Rivipansel (Drug)
Severe Renal Impairment
A single dose of IV Rivipansel over 20 minutes
干预措施: Rivipansel (Drug)
Normal Renal Functions
A single dose of IV Rivipansel over 20 minutes
干预措施: Rivipansel (Drug)
结局指标
主要结局
Clearance (CL)
时间窗: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration
Renal clearance
时间窗: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration
Area under the concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, as data permit
时间窗: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration
Assessment of 12-lead electrocardiograms
时间窗: Baseline up to 96 hours
Assessment of laboratory tests
时间窗: Baseline up to 96 hours
Physical examination
时间窗: Baseline up to 96 hours
Assessment of adverse events
时间窗: Baseline up to 28 days
Assessment of vital signs
时间窗: Baseline up to 96 hours
次要结局
- Apparent volume of distribution(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)
- Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)
- Time to reach maximum concentration(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)
- Peak or maximum observed concentration(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)
- Terminal half life(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)
- Percentage of dose excreted unchanged into urine over 96 hours(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)
- Fraction of unbound(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)
- Amount of unchanged drug excreted into urine over 96 hours(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration)