NCT00933972已完成1 期
Effect of Renal Impairment on Pharmacodynamics and Pharmacokinetics of RO4998452: A Multiple-center, Open-label, Parallel Group Study Following Single Oral Dosing of RO4998452 to Type 2 Diabetes Patients With Varying Degrees of Renal Impairment.
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
- 36
- 主要终点
- Creatinine clearance; Pk parameters; adverse events
研究概览
简要总结
This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be divided into 4 groups, with normal renal function, or mild, moderate or severe renal impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The anticipated time on study treatment is <3 months (single dose study)and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 40-80 years of age;
- •type 2 diabetes;
- •normal renal function, or impaired but stable renal function;
- •stable with regard to medication or treatment regimen taken for renal impairment or diabetes.
排除标准
- •patients with a renal transplant;
- •end-stage renal disease, requiring dialysis;
- •nephrotic syndrome, or a history of nephrectomy;
- •type 1 diabetes mellitus.
研究组 & 干预措施
1 (normal)
Experimental
干预措施: RO4998452 (Drug)
2 (mild)
Experimental
干预措施: RO4998452 (Drug)
3 (moderate)
Experimental
干预措施: RO4998452 (Drug)
4 (severe)
Experimental
干预措施: RO4998452 (Drug)
结局指标
主要结局
Creatinine clearance; Pk parameters; adverse events
时间窗: Days 1-3
次要结局
- Blood glucose; meal tolerance test(Days 1-3)
研究者
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