NCT00621881已完成1 期
A Phase 1, Repeated-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750 mg Bid Administered to Patients With Impaired Hepatic Function Compared to Matching Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- NicOx
- 入组人数
- 24
- 主要终点
- To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects
研究概览
简要总结
This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.
详细描述
This is an open-label, non-randomized, parallel-group study that will be conducted at two study sites. Patients with hepatic impairment and matched healthy subjects will receive naproxcinod 750 mg bid for 6 days and qd for the last day.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female, age 40 to 75 years with stable hepatic insufficiency conforming to Child-Pugh classification B OR
- •Male or Female, age 40 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health
排除标准
- •Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except lose dose aspirin
- •History of renal impairment
- •Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
- •Clinically relevant abnormal ECG
- •Alcohol or drug abuse within the last 6 months
- •Any significant or chronic disease (except hepatic insufficiency for the patient cohort) which may interfere with study evaluations
研究组 & 干预措施
1
Experimental
750 mg naproxcinod
干预措施: naproxcinod (Drug)
结局指标
主要结局
To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects
时间窗: 8 days
次要结局
- To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects.(8 days)
研究者
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