NCT01367509已完成1 期
A Phase 1, Open-Label Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired 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
- 32
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of MNTX in patients with impaired renal function compared to healthy subjects
研究概览
简要总结
This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight >100 lbs. (> 45 kg), and body mass index (BMI) between 18-38 kg/m2, inclusive (BMI 18-30 for the matched reference group)
- •For patients/subjects requiring pharmacotherapy, a stable drug regimen, defined as not having started a new drug or changed dosage within three (3) days or five (5) half-lives (whichever was longer) prior to administration of MNTX concomitant medication must either have conformed to the list of approved drugs and dosage or have been approved by the sponsor.
- •Patients with normal renal function, demographically comparable to the patients with impaired renal function weights and ages were within the range of chronic kidney disease (CKD) group and the average for the matched reference group was within 10 years and 10 kg of the average for the CKD
- •Patients with impaired renal function, good general health except for those illnesses associated with CKD.
排除标准
- •Subjects/patients with any conditions possibly affecting drug absorption (eg. Gastrectomy or clinically significant diabetic gastroenteropathy)
- •Methadone use
- •Consumption of grapefruit or grapefruit juice within seven (7) days prior to administration of study medication.
- •Patients requiring hemodialysis.
研究组 & 干预措施
Arm 1
Experimental
SC Methylnaltrexone (MNTX)
干预措施: Methylnaltrexone (MNTX) (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of MNTX in patients with impaired renal function compared to healthy subjects
时间窗: 6 days
To compare the PK of MNTX administered subcutaneously as a single dose in patients with impaired renal function with the PK of MNTX administered to healthy subjects.
次要结局
- Area under the plasma concentration (AUC) of MNTX in patients with impaired renal function compared to healthy subjects(6 days)
- Peak time of maximum concentration (Tmax) of MNTX in patients with impaired renal function compared to healthy subjects(6 days)
- Urinary clearance of MNTX in patients with impaired renal function compared to healthy subjects(6 days)
- Percent of dose excreted in urine of MNTX in patients with impaired renal function compared to healthy subjects(6 days)
研究者
研究点 (1)
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