A Single-center, Non-randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and End-stage Renal Disease Without Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC
研究概览
简要总结
This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, age 18 to 70 years of age, inclusive;
- •must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening;
- •Glomerular filtration rate must be < 15 mL/min /1.73 m2 for End-stage renal disease without hemodialysis group, and ≥ 90 mL/min for Normal Renal Function group(using MDRD method);
- •matched for age (±5 years) ,gender and BMI(±15%) with a subject in the End-stage renal disease without hemodialysis group;
排除标准
- •allergies constitution ( multiple drug and food allergies);
- •Use of >5 cigarettes per day during the past 3 months;
- •A positive test results for HbsAg, Hepatitis C antibody, HIV-1 antibody, or Treponema pallidum antibody；
- •History of alcohol abuse；
- •Donation or loss of blood over 400 mL within 3 months prior to the first dose of study drug；
- •Subjects deemed unsuitable by the investigator for any other reason.
研究组 & 干预措施
Participants with renal impairment
Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule.
干预措施: Yimitasvir Phosphate Capsule (Drug)
Participants with normal renal function
Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule.
干预措施: Yimitasvir Phosphate Capsule (Drug)
结局指标
主要结局
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC
时间窗: From Days 1-5
AUC is defined as the concentration of drug area under the curve
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax
时间窗: From Days 1-5
Cmax is defined as the maximum concentration of drug
次要结局
- Incidence of adverse events(From Days 1-5)