NCT01456663已完成1 期
A Single-dose, Open-label, Parallel Study to Assess the Pharmacokinetics of AFQ056 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups
研究概览
简要总结
This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Groups 1, 2, 3 and 4 (all subjects)
- •Male and female Caucasian subjects
- •Group 1, 2 and 3 (subjects with hepatic impairment)
- •Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening
- •Group 4 (healthy subjects)
- •Each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3.
排除标准
- •Groups 1, 2, 3 and 4 (all subjects)
- •Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion.
- •Group 1, 2 and 3 (subjects with hepatic impairment)
- •History of drug or alcohol abuse within 3 months prior to screening
- •History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition.
- •Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
- •History or presence of encephalopathy within 6 months prior screening (except for subjects in Groups 2 and 3).
- •Documented presence of a porto-systemic shunt.
- •Documented presence of esophagus varices (stage III or IV).
- •Group 4 (healthy subjects)
- •History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.
- •History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AFQ056
Experimental
干预措施: AFQ056 (Drug)
结局指标
主要结局
Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups
时间窗: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose
AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F
次要结局
- Measure: Plasma protein binding results of AFQ056 in each groups.(2 hours after single dose administration)
- Measure: : Number of subjects with adverse event in each group(From dose administration (day 1) to 13+/- 2 days after the single dose administration)
研究者
研究点 (1)
Loading locations...
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