NCT01241669已完成1 期
A Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Multiple Doses of E5555 on the Pharmacokinetics of Metformin (a Substrate for OCT2 Transporter) and on Renal Function in 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
- Eisai Inc.
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.
研究概览
简要总结
This is a drug-drug interaction study to evaluate the effects of steady-state exposure of E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of E5555 on several renal function parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects aged greater than or equal to 18 years to 55 years
排除标准
- •History of any medical condition which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis, etc.
- •Creatinine clearance < 90 mL/min as estimated using Cockcroft-Gault formula at screening or baseline
- •History of any renal disorders, proteinuria, hepato-biliary disease.
研究组 & 干预措施
Arm 1
Experimental
干预措施: E5555 (Drug)
Arm 2
Experimental
干预措施: E5555 (Drug)
结局指标
主要结局
To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.
时间窗: 15 days
次要结局
- To assess the effects of multiple doses of E5555 on the glomerular filtration rate estimated using iohexol.(Days 7 and 14)
- To assess the effects of multiple doses of E5555 on the effective renal plasma flow estimated using para-aminohippuric acid (PAH).(Days 7 and 14)
- To assess the multiple dose pharmacokinetics of E5555 and its main 6 metabolites.(Days 12-18)
- To assess the safety and tolerability of multiple doses of E5555 and a single dose of metformin either given alone or concomitantly(Day 1 - Day 18)
研究者
研究点 (1)
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