NCT04221399Unknown1 期
A Single- and Multiple-Dose Clinical Study to Evaluate Pharmacokinetics and Pharmacodynamics of DWP16001 Following Oral Dose in Type 2 Diabetes Patients With Renal Impairment
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 35 人开始时间: 2020年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 35
- 主要终点
- Concentration-time curve [AUC]
研究概览
简要总结
The purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of DWP16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal impairment.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 19 years at the time of screening test
- •Body weight of ≥ 50.0 kg to ≤ 90.0 with a body mass index (BMI) of ≥ 20.0 to ≤ 45.0
- •Have been diagnosed with type 2 diabetes
排除标准
- •Have clinically uncontrolled or unstable hepatic, neurological, immune system, respiratory, hemato-oncology, cardiovascular, or psychiatric disorder (subject with chronic disease such as hypertension, diabetes, and hyperlipidemia that is well controlled or stable is eligible to participate in the study based on investigator's judgement)
- •History of gastrointestinal diseases, dialysis, kidney transplantation, HIV, hepatitis B or C, acute or chronic infection, recent diabetic ketoacidosis, or gastrointestinal surgery that may affect the absorption of the study drug
- •Received SGLT2 inhibitors or drugs of thiazolidinedione class within 6 weeks of scheduled IP administration day
- •Clinical laboratory test values are outside the accepted normal range at screening
- •AST (SGOT), ALT (SGPT) > 2 x the upper limit of normal
- •Repeatedly confirmed QTc interval > 450 ms
- •Sitting systolic blood pressure < 80 mmHg or > 180 mmHg or sitting diastolic blood pressure < 60 mmHg or > 110 mmHg after resting for more than 3 minutes
- •Other exclusive inclusion criteria, as defined in the protocol
研究组 & 干预措施
DWP16001 Single dose
Experimental
Single dose
干预措施: DWP16001 (Drug)
DWP16001 Multiple dose
Experimental
Up to 7 days
干预措施: DWP16001 (Drug)
结局指标
主要结局
Concentration-time curve [AUC]
时间窗: on Days 1 to 4 at selected time points
Concentration of serum glucose
时间窗: on Days 1 to 4 at selected time points
Maximum Plasma Concentration [Cmax]
时间窗: on Days 1 to 4 at selected time points
Urine glucose (g/day)
时间窗: on Days -1 to 4
Cummulative by time
次要结局
未报告次要终点
研究者
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