NCT00731523已完成1 期
An Open-label, Single-dose, Parallel-group Study to Compare the Pharmacokinetics of FTY720 and Metabolites in Subjects With Severe Renal Impairment With That in Matched Healthy Control 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
- Novartis
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in patients with severe renal insufficiency and in matched, healthy volunteers. This study will allow a better understanding of the effects of renal insufficiency on the disposition of FTY720.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects:
- •Subjects must have a calculated glomerular filtration rate (GFR) by Cockcroft-Gault Equation ≥80 mL/min.
- •Severe Renal Impaired Patients:
- •Patients not on dialysis with severe renal failure with a creatinine clearance < 30 mL/min as determined by Cockcroft-Gault Equation.
- •Renal function should have been stable within the 3 months prior to study start.
- •Patients with diabetes and/or hypertension who are in otherwise in good health may be included. However patients with diabetes must not have clinical evidence of gastropathy or enteropathy.
排除标准
- •All Subjects/Patients:
- •History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study
- •History of retinal macular edema.
- •History of any significant cardiovascular events such as myocardia infarction, valvular disease, angina, ischemic heart disease, dilated cardiomyopathy, dysrhythmia.
- •History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
- •Severe Renal Impaired Patients:
- •Use of any highly potent CYP3A4 inhibitor (e.g. erythromycin, ketoconazole, itraconazole) within 2 weeks prior to dosing.
- •Use of beta blocker therapy within two (2) weeks prior to dosing.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
干预措施: fingolimod (FTY720) (Drug)
结局指标
主要结局
PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks
次要结局
- Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks
- Assess the safety and tolerability, 3 weeks
研究者
研究点 (1)
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