NCT00596518已完成1 期
A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the curve from time 0 until last observation (AUCtlast)
研究概览
简要总结
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
- •Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
- •Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications
排除标准
- •Women who are pregnant, nursing or women of childbearing potential
- •Subjects with acute renal disease.
研究组 & 干预措施
PF-00734200
Experimental
干预措施: PF-00734200 (Drug)
结局指标
主要结局
Area under the curve from time 0 until last observation (AUCtlast)
时间窗: 3-6 days
Maximum serum concentration (Cmax)
时间窗: 3-6 days
次要结局
- Half life (T1/2)(3-6 days)
- Renal clearance (CLr)(3-6 days)
- Time of Cmax (Tmax)(3-6 days)
- AUC extrapolated to infinity (AUCinf)(3-6 days)
- Hemodialysis clearance (CLd)(3 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetic Study of Primaquine in Healthy Obese Thai Adult SubjectsObeseNCT02789566University of Oxford10
已完成
1 期
Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual OnychomycosisOnychomycosis of ToenailNCT05110638SATO Pharmaceutical Co., Ltd.19
已完成
1 期
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2Healthy VolunteersNCT02249728Prana Biotechnology Limited6
已完成
1 期
STUDY TO COMPARE PHARMACOKINETICS (PK) OF SINGLE ORAL DOSES OF DIFFERENT PF-06882961 FORMULATIONS IN PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITYOverweight and/or ObesityNCT04616339Pfizer31
已完成
1 期
A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise HealthyHealthy VolunteerNCT04839393Pfizer27