A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis
研究概览
简要总结
- Quantify how much PD-0332334 is removed from the blood with hemodialysis
- Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
- Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.
详细描述
Assess the elimination of PD-0332334 from the blood with hemodialysis
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving regular hemodialysis
- •Male or female patients 18 to 65 years
排除标准
- •Severe heart failure
- •Renal transplant or renal allograft
- •Illicit drug use (with the exception of prescribed sedatives)
研究组 & 干预措施
PD-0332334
干预措施: PD-0332334 (Drug)
结局指标
主要结局
Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis
时间窗: 0 to 8 days
Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis
时间窗: 0 to 8 days
Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast).
时间窗: 0 to 8 days
次要结局
- Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.(0 to 8 days)