An Phase I, Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ADC189 in Subjects With Hepatic Impairment (Child-Pugh A and B) Compared With Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax of ADC189/ADC189-I07
研究概览
简要总结
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.
详细描述
The evaluation of ADC189/ADC189-I07 in mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B) the pharmacokinetic characteristics in subjects, compared with normal liver function subjects, which matched by sex, age, and BMI, in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •The subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial.
- •Age 18-75 years old (including the boundary value), both male and female.
- •The body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (BMI) was within the range of 18.0~30.0 kg/m².
排除标准
- •Known allergic history to test drug components, or allergic constitution, or history of allergic diseases.
- •Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening.
- •Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening.
- •eGFR (CKD-EPI Cr) <60mL/min/1.73m2.
研究组 & 干预措施
ADC189 to Child-Pugh Class A
Subjects with Child-Pugh Class A received a single dose once of ADC189 (45 mg/1 tablet).
干预措施: ADC189 (Drug)
ADC189 to normal haptic function (A)
Healthy subjects who marched with Group "Child-Pugh Class A", that received a single dose of ADC189 (45 mg/1 tablet).
干预措施: ADC189 (Drug)
ADC189 to Child-Pugh Class B
Subjects with Child-Pugh Class B received a single dose once of ADC189 (45 mg/1 tablet).
干预措施: ADC189 (Drug)
ADC189 to normal haptic function (B)
Healthy subjects who marched with Group "Child-Pugh Class B", that received a single dose of ADC189 (45 mg/1 tablet).
干预措施: ADC189 (Drug)
结局指标
主要结局
Cmax of ADC189/ADC189-I07
时间窗: 15 days
AUClast of ADC189/ADC189-I07
时间窗: 15 days
次要结局
未报告次要终点