NCT01510899已完成1 期
A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
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
- 12
- 主要终点
- Pharmacokinetics: Area under concentration time curve of RO4917838
研究概览
简要总结
This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •General criteria
- •Body mass index (BMI) between 18 and 32 kg/m2
- •Criteria applying to renal impaired subjects
- •Adult subjects, 18-65 years of age
- •Part 1: Subjects with end stage renal disease (ESRD), not on dialysis
- •Part 2: Subjects with severe, moderate or mild renal impairment
- •Stable renal function
- •Criteria applying to healthy subjects
- •Adult subjects, 18-70 years of age
排除标准
- •General criteria
- •Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk
- •Any condition which could relapse during or immediately after the study
- •History of alcohol or drug abuse
- •Criteria applying to renal impaired subjects
- •Evidence of unstable clinically significant disease other than renal impairment
- •Clinically significant liver disease
- •Any other major illness (with the exception of renal impairment) within 4 weeks prior to study start
- •Criteria applying to healthy subjects
- •History of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)
研究组 & 干预措施
Healthy Subjects Arm
Experimental
干预措施: RO4917838 (Drug)
Renal Impaired Subjects Arm
Experimental
干预措施: RO4917838 (Drug)
结局指标
主要结局
Pharmacokinetics: Area under concentration time curve of RO4917838
时间窗: Days 1-16
次要结局
- Safety: Incidence of adverse events(9 weeks)
研究者
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