Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
研究概览
简要总结
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min
- •Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease
排除标准
- •Kidney transplant patients
- •Subjects with any condition possibly affecting drug absorption
- •Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin
研究组 & 干预措施
Mild renal impairment
patients with mild (>50 and ≤80 mL/min) renal impairment
干预措施: CP-690,550 (Drug)
Healthy volunteers
Healthy volunteers
干预措施: CP-690,550 (Drug)
Moderate renal impairment
patients with moderate (≥30 and ≤50 mL/min) renal impairment
干预措施: CP-690,550 (Drug)
severe renal impairment
patients with severe (<30 mL/min) renal impairment
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Plasma Decay Half-Life (t1/2)
时间窗: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Renal Clearance (CL R)
时间窗: 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.
次要结局
未报告次要终点