NCT00651027已完成1 期
An Open Label Study, To Evaluate The Pharmacokinetics, Safety And Toleration Of A Single Oral Dose Of Pf-00868554 In Subjects With Hepatic Impairment To Subjects With Normal Hepatic 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
- 24
- 试验地点
- 1
- 主要终点
- PK parameters
研究概览
简要总结
The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety and toleration of 200 mg PF-00868554 administered as a single-dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive;
- •Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh >50 kg (110 lbs);
排除标准
- •Subjects with Class C classification (Severe - Child-Pugh Scores greater than 10);
- •Severe ascites and/or pleural effusion;
- •Had a transplanted kidney, heart or liver;
研究组 & 干预措施
A
Experimental
干预措施: PF-868554 (Drug)
B
Experimental
干预措施: PF-868554 (Drug)
C
Experimental
200 mg
干预措施: PF-868554 (Drug)
结局指标
主要结局
PK parameters
时间窗: 8 day
次要结局
- safety and tolerability(8days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Drug-Drug Interaction Study: ASP2151 and MidazolamHealthyNCT02403635Maruho Europe Limited27
已完成
1 期
A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001Fungal InfectionNCT04166669Basilea Pharmaceutica36
已完成
1 期
Understanding The Effect Of A Strong CYP3A4 Inducer On Glasdegib PharmacokineticsHealthy VolunteersNCT02430545Pfizer12
已完成
4 期
Physiological Study of the Human CYP3A Activity (PiSA)Cytochrome P450 CYP3A Enzyme DeficiencyNCT03204578University Hospital, Basel, Switzerland12
已完成
1 期
Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy AdultsHealthy VolunteersNCT03264079Biogen16