An Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics/Pharmacodynamics and Safety of GK Activator (2) Following a Single Oral Dose Administration in Patients With Type 2 Diabetes.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Vital signs, adverse events, laboratory parameters.
研究概览
简要总结
This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is <3 months, 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2);
- •normal renal function, or moderate or severe impairment.
排除标准
- •type 1 diabetes;
- •treatment with insulin or PPAR gamma agonist within 6 months of screening.
研究组 & 干预措施
1
干预措施: GK Activator (2) (Drug)
2
干预措施: GK Activator (2) (Drug)
3
干预措施: GK Activator (2) (Drug)
结局指标
主要结局
Vital signs, adverse events, laboratory parameters.
时间窗: Throughout study
次要结局
- AUC, Tmax, Cmax, T1/2, CL/F, CLR for GK Activator (2) and metabolite. Glucose Cmax and Cmin, and percentage decrease in glucose from baseline.(Throughout study.)