NCT05747664招募中1 期
An Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DWP16001 in Subjects With Hepatic Impairment Compared With Subjects With Normal Hepatic Function
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUClast of DWP16001
研究概览
简要总结
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.
详细描述
The study design is An open-label, multi-center, parallel, single oral dose study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
- •A person who is 19 years of age or more and under 80 years of age at the time of screening.
- •Those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
排除标准
- •A person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of DWP
- •Those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the SGLT2 inhibitor family or who have a history of clinically significant hypersensitivity reaction.
- •Serum Cr >1.5mg/dL or eGFR (CKD-EPI Cr) <60mL/min/1.73m2
- •Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.
研究组 & 干预措施
DWP16001 to normal haptic function
Experimental
Normal hepatic function
干预措施: DWP16001 (Drug)
DWP16001 to Child-Pugh Class A
Experimental
Child-Pugh Class A
干预措施: DWP16001 (Drug)
DWP16001 to Child-Pugh Class B
Experimental
Child-Pugh Class B
干预措施: DWP16001 (Drug)
结局指标
主要结局
AUClast of DWP16001
时间窗: 0 to 48 hours
AUClast of DWP16001
Cmax of DWP16001
时间窗: 0 to 48 hours
Cmax of DWP16001
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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