A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
研究概览
简要总结
- To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
- To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
详细描述
Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.
On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
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
- 是
入选标准
- •Healthy volunteers OR subjects with kidney impairment
排除标准
- •Receiving hemodialysis
- •clinically significant or unstable medical disease other than kidney disease
研究组 & 干预措施
Group 1-Normal
干预措施: PD 0332334 (Drug)
Group 4-Severe
干预措施: PD 0332334 (Drug)
Group 3-Moderate
干预措施: PD 0332334 (Drug)
Group 2-Mild
干预措施: PD 0332334 (Drug)
结局指标
主要结局
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
时间窗: 1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
时间窗: 5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
时间窗: 5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
时间窗: 5 to 17 days depending on cohort
次要结局
- Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs(5 to 17 days)