A Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Subjects With Impaired Hepatic Function
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
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
研究概览
简要总结
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of reduced hepatic function (Child Pugh Classification A or B)
- •Body Mass Index of 18-32 kg/m2
排除标准
- •History of febrile illness within 5 days prior to first dose
- •Any condition possibly affecting drug absorption (e.g. gastrectomy)
- •Positive urine drug screen
研究组 & 干预措施
Hepatic Function - Mild Impairment
Subjects with mild hepatic impairment (Child Pugh class A, score 5-6)
干预措施: AG-013736 (Drug)
Hepatic Function - Moderate Impairment
Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9)
干预措施: AG-013736 (Drug)
Hepatic Function - Normal
Group 1
- subjects with normal hepatic function
干预措施: AG-013736 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hours (hrs) post-dose
次要结局
- Apparent Oral Clearance (CL/F)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Apparent Volume of Distribution (Vz/F)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Fraction of Unbound Drug (fu)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Unbound Maximum Observed Plasma Concentration (Cmaxu)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Plasma Elimination Half-life (t1/2)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Unbound Apparent Volume of Distribution (Vzu/F)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u](0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)
- Unbound Apparent Oral Clearance (CLu/F)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose)