NCT01374113已完成1 期
An Open-label, Parallel-group, Single Center, Single Oral Dose Trial to Investigate the Pharmacokinetics (PK) of 50 mg Safinamide in Subjects With Moderate and Severe Renal Impairment Compared to Matched Subjects With Normal Renal 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
- Cmax of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide
研究概览
简要总结
The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal renal 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
- •Renally impaired subjects - Subject with different degrees of renal impairment: moderate and severe renal impairment as assessed by Estimated Glomerular Filtration Rate (eGFR) according to Modification of Diet in Renal Disease (MDRD) equation at screening
- •Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, electrocardiogram (ECG) and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to dosing
- •All subjects have given written informed consent before any study-related activities are carried out
排除标准
- •Any other clinically relevant disease, condition, or therapy, which in the Investigator's opinion would exclude the subject from the trial, may pose a risk to the subject or interfere with the trial objectives.
- •Existence of surgical or medical condition, which, in the judgment of the Investigator, might interfere with the absorption, metabolism, or excretion of the drug and/or gastrointestinal motility
- •Renally impaired subjects - Acute renal failure of any etiology (including viral, toxic, or drug induced), renal transplantation within the previous 12 months, uncontrolled diabetes mellitus as judged by the Investigator, use of any drug affecting gastric acid secretion, such as proton pump inhibitors and antacids received within 48 hours prior to drug administration and for 24 hours after administration, Chronic heart failure (CHF) New York Heart Association (NYHA) class III and IV despite treatment at screening, change in used medication (prescribed by a physician or over-the-counter [OTC] medication) within 14 days prior to safinamide administration. Concomitant medication used for the treatment of renal impairment and accompanying diseases may be continued during the trial.
- •Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to 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 trial drug administration.
研究组 & 干预措施
Group 1
Experimental
Subjects with moderate renal impairment
干预措施: 50mg safinamide (Drug)
Group 2
Experimental
Subjects with severe renal impairment
干预措施: 50mg safinamide (Drug)
Group 3
Experimental
Matched subjects with normal renal function
干预措施: 50mg safinamide (Drug)
结局指标
主要结局
Cmax of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide
时间窗: 12 to 14 days
AUC0-∞ of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide
时间窗: 12 to 14 days
次要结局
- Cmax of safinamide metabolite NW-1689 in plasma(12 to 14 days)
- Cmax of safinamide metabolite NW-1153 in plasma(12 to 14 days)
- Cmax of safinamide metabolite NW-1689 acylglucuronide in plasma(12 to 14 days)
- AUC0-∞ of safinamide metabolite NW-1689 in plasma(12 to 14 days)
- AUC0-∞ of safinamide metabolite NW-1153 in plasma(12 to 14 days)
- AUC0-∞ of safinamide metabolite NW-1689 acylglucuronide in plasma(12 to 14 days)
研究者
研究点 (1)
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