A Phase 1, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Apparent terminal elimination half-life (t1/2)
研究概览
简要总结
This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18 to 38 kg/m2
- •diagnosis of chronic or stable hepatic insufficiency, with a Child-Pugh classification scores of mild, moderate or severe.
排除标准
- •Current or previous history of hepatic carcinoma, hepatorenal syndrome, portacaval shunt surgery, significant hepatic encephalopathy, severe ascites, or pleural effusion
- •Currently undergoing dialysis
- •Poor peripheral venous access
- •Pregnancy or lactation
结局指标
主要结局
Apparent terminal elimination half-life (t1/2)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Apparent total clearance (CL/F)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Apparent volume of distribution (Vz/F)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Maximum Observed Concentration (Cmax)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Time to maximum concentration (Tmax)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0 t)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Area under the concentration-time curve extrapolated to infinity (AUC0-∞)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Apparent terminal elimination rate constant (λz)
时间窗: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
次要结局
- Change from baseline in physical examinations(Baseline and End of Study Visit (Day 30))
- Change from baseline in thyroid function tests(Baseline and End of Study Visit (Day 30))
- Change from baseline in electrocardiograms(Baseline and End of Study Visit (Day 30))
- Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)(up to 16 weeks)
- Change from baseline in vital signs(Baseline and End of Study Visit (Day 30))
- Change from baseline in chemistry assessments(Baseline and End of Study Visit (Day 30))
- Change from baseline in urinalysis assessments(Baseline and End of Study Visit (Day 30))
- Change from baseline in hematology including coagulation assessments(Baseline and End of Study Visit (Day 30))