A Nonrandomized, Open Label Study to Examine the Effect of Hepatic Impairment on the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.'
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose.
研究概览
简要总结
This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. 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;
- •normal hepatic function, or mild or moderate hepatic impairment.
排除标准
- •type 1 diabetes, or latent autoimmune diabetes in adults;
- •diabetic neuropathy, retinopathy or nephropathy;
- •treatment with insulin or PPAR gamma agonist within 6 weeks of screening;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
1
干预措施: GK Activator (2) (Drug)
2
干预措施: Ethanol (Drug)
3
干预措施: GK Activator (2) (Drug)
3
干预措施: Ethanol (Drug)
结局指标
主要结局
AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose.
时间窗: Days 1, 8 and 15
次要结局
- tmax, AUC0-6, AUC0-last, t1/2, CL/F, Ac, CL for GK Activator (2) and M4. Cmin, Cmax, tmax and tmin of plasma glucose.(Days 1, 8 and 15)
- AEs, laboratory parameters.(Throughout study)