An Open-Label, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Effect of Renal Function on Maximum Plasma Concentration of TA-7284
研究概览
简要总结
The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.
详细描述
This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.
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
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
- •Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
- •HbA1c of ≥6.5% and ≤10.5% at screening
排除标准
- •Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
- •Past or current history of severe diabetic complications
- •Patients requiring insulin therapy
- •History of hereditary glucose-galactose malabsorption or primary renal glucosuria
研究组 & 干预措施
TA-7284 Low
干预措施: TA-7284 Low (Drug)
TA-7284 High
干预措施: TA-7284 High (Drug)
结局指标
主要结局
Effect of Renal Function on Maximum Plasma Concentration of TA-7284
时间窗: For 72 hours after each administration
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
时间窗: For 72 hours after each administration
Effect of Renal Function on Urinary Glucose Excretion of TA-7284
时间窗: For 24 hours after each administration
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284
时间窗: For 24 hours after each administration
The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.
次要结局
- Adverse Events(Upto approximately 14 days after last administration)
- 12-lead Electrocardiogram (ECG)(For 72 hours after each administration)
- Vital Signs(For 72 hours after each administration)
- Clinical Laboratory Tests(For 72 hours after each administration)