NCT01027169已完成1 期
An Open-label, Parallel-group, Single Centre, Single Oral Dose Study to Investigate the Pharmacokinetics of 50 mg Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Matched 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
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of safinamide after single dose administration (Cmax)
研究概览
简要总结
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Hepatically impaired subjects - Subjects with liver cirrhosis and different degrees of impaired hepatic function: mild and moderate impaired hepatic function (Grade A, or B according to Child-Pugh classification)
- •Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, ECG and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to the dosing
- •All subject have given written informed consent before any study-related activities are carried out
排除标准
- •Any clinically relevant disease or condition, which in the Investigator's opinion would exclude the subject from the study
- •Diseases or surgeries of the gastrointestinal tract, which could influence the gastro-intestinal absorption and/or motility
- •Hepatically impaired subjects - Subjects with primary biliary liver cirrhosis, hepatic encephalopathy grade III and IV, sepsis or spontaneous bacterial peritonitis, gastrointestinal bleeding within one month before the study, esophagus varices > grade II, acute hepatic failure of any aetiology, portosystemic shunt, renal impairment (creatinine clearance < 50 mL/min calculated by use of Cockroft Gault formula)
- •Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to the drug administration, or within six times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before study drug administration
研究组 & 干预措施
Arm 2
Experimental
subjects with moderate hepatic impairment
干预措施: safinamide (Drug)
Arm 3
Experimental
matched subjects with normal hepatic function
干预措施: safinamide (Drug)
Arm 1
Experimental
subjects with mild hepatic impairment
干预措施: safinamide (Drug)
结局指标
主要结局
Pharmacokinetics of safinamide after single dose administration (Cmax)
时间窗: 10 days
Pharmacokinetics of safinamide after single dose administration (AUC)
时间窗: 10 days
次要结局
- Safety and tolerability after single dose administration of safinamide (Adverse Events)(12 days)
- Pharmacokinetics of safinamide metabolite NW1153 (Cmax)(10 days)
- Pharmacokinetics of safinamide metabolite NW1153 (AUC)(10 days)
- Pharmacokinetics of safinamide metabolite NW1689 (Cmax)(10 days)
- Pharmacokinetics of safinamide metabolite NW1689 (AUC)(10 days)
研究者
研究点 (1)
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