NCT01367522
已完成
1 期
A Phase 1, Open-Label, Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Volunteers With Impaired Hepatic Function
概览
- 阶段
- 1 期
- 干预措施
- SC Methylnaltrexone (MNTX)
- 疾病 / 适应症
- Liver Dysfunction
- 发起方
- Bausch Health Americas, Inc.
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma Concentration of SC MNTX
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight subjects from each classification of hepatic impairment will be enrolled. Plasma samples will be collected before and at specified intervals after dosing and the concentration of MNTX will be analyzed.
研究者
入排标准
入选标准
- •Males and females between the ages of 18-80 years
- •Body weight greater than 100 lbs and BMI between 18-38
- •Liver values that are abnormal must not be clinically relevant as judged by the investigator. Liver enzyme and bilirubin must be less than 5 times the upper normal of reference range and may be repeated under fed conditions if abnormal. Stable hepatitis patients as well as cirrhosis patients of either etiology.
排除标准
- •History of current alcohol abuse with less than 1 year abstinence
- •Conditions possibly affecting drug absorption, e.g. gastrectomy or clinically significant diabetic gastroenteropathy.
- •Currently pregnant or nursing
- •Methadone use.
研究组 & 干预措施
Arm 1
干预措施: SC Methylnaltrexone (MNTX)
结局指标
主要结局
Plasma Concentration of SC MNTX
时间窗: 20 days
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.
次要结局
- Area Under the Plasma Concentration versus Time Curve (AUC) of SC MNTX(20 days)
- Time of Maximum Plasma Concentration of SC MNTX(20 days)
- Percentage of SC MNTX Excreted in Urine(20 days)
- Urinary Clearance of SC MNTX(20 days)
研究点 (1)
Loading locations...
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