An Interventional, Single-site, Open-label, Four-group, Single-dose Study Investigating the Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment (Mild, Moderate, or Severe) and in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t)
研究概览
简要总结
To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young subjects and subjects with renal impairment with a Glomerular Filtration Rate (GFR) of 50-80 ml/min/1.73m2, 30-<50 ml/min/1.73m2, <30 ml/min/1.73m2 will be included in the study.
- •The subjects must have a BMI between 19 and 32 kg/m2.
排除标准
- •The subject has a history of renal transplant or is undergoing dialyse treatment.
- •The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Nalmefene 18 mg
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
干预措施: Nalmefene 18 mg (Drug)
结局指标
主要结局
For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t)
时间窗: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)
时间窗: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)
时间窗: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)
时间窗: Up to 120 hours post-dose
For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)
时间窗: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)
时间窗: Up to 120 hours post-dose
For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent
时间窗: Up to 120 hours post-dose
For nalmefene: apparent volume of distribution for nalmefene (Vz /F)
时间窗: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)
时间窗: Up to 120 hours post-dose
次要结局
- Safety and tolerability(Up to 10 days)