NCT01099904已完成1 期
The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
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
- 30
- 主要终点
- Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl
研究概览
简要总结
This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is <50.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female adults, 18-75 years of age
- •normal, or mildly or moderately impaired renal function (creatinine clearance >/= 30 mL/min)
- •BMI 18-40 kg/m2
- •stable renal function
- •agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
- •agree to abstain from coffein consumption throughout study
排除标准
- •positive urine or blood test for drugs of abuse not under a physician's prescription
- •positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
- •uncontrolled hypertension
- •renal transplant, dialysis patient, nephritic syndrome
- •clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder
研究组 & 干预措施
1
Experimental
Normal Renal Function
干预措施: RO5024048 (Drug)
2
Experimental
Mild Renal Impairment
干预措施: RO5024048 (Drug)
3
Experimental
Moderate Renal Impairment
干预措施: RO5024048 (Drug)
结局指标
主要结局
Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl
时间窗: sampling days 1 and 3-11
次要结局
- Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters(Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17)
研究者
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