NCT05916573已完成1 期
A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年12月12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
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AUC0-inf
研究概览
简要总结
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of HSK16149 in subjects with mild, moderate and severe renal impairment compared to the matched control subjects with normal renal function.
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
- 是
入选标准
- •Subjects with renal impairment(RI):
- •Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- •18 years to 75 years (inclusive), male and female;
- •Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m^2));
- •Subjects with medically stable RI until study completion corresponding to the classifications of Renal Function based on GFR: mild RI: 60≤GFR<90 mL/min; moderate RI: 30≤GFR<60 mL/min, severe RI:15≤GFR<30 mL/min;
- •Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;
- •Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for RI/ other comorbidities (last more than four weeks in good compliance);
- •Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.
- •Subjects with normal renal function :
- •Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- •18 years to 75 years (inclusive), male and female, age and sex must be matched with subjects with RI;
- •Male subjects weight ≥50 kg and female subjects weight ≥45 kg, weight must be matched with subjects with RI. Body mass index (BMI) : 18-30 kg/m^2 (inclusive) (BMI= weight (kg)/height2 (m^2));
- •90≤GFR<130 mL/min;
- •Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;
- •Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for comorbidities (last more than four weeks in good compliance);
- •Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.
排除标准
- •Allergic to any component in HSK16149 capsules;
- •Uncontrolled or unstable cardiovascular, respiratory, liver, gastrointestinal tract, endocrine, blood, mental/nervous, etc.Systemic diseases;
- •Those who have committed suicide or suicidal tendency in the past, or those who have recurrent dizziness, headache, memory and cognitive impairment;
- •According to the researcher's judgment, there are factors that affect the absorption, distribution, metabolism and excretion of drugs, such as diseases, drugs, surgery, etc.; Taking Niaoduqing granules, the stool is irregular or shapeless;
- •Acute renal failure;
- •Smoking more than 5 cigarettes a day on average in the 3 months before screening or unable to stop using any tobacco products during the test period;
- •Drinking more than 14 units per week within 3 months before screening (1 unit = 17.7 mL ethanol, that is, 1 unit =357 mL beer with 5% alcohol content, 43 mL white wine with 40% alcohol content or 147 mL wine with 12% alcohol content), or those who can't ban alcohol during the test, or those who are positive in alcohol breath test;
- •Have a history of drug abuse within 5 years before screening, or have a positive drug abuse screening;
- •Those who have ingested beverages or foods rich in xanthine (coffee, tea, chocolate, etc.) or grapefruit for a long time in the past, or have taken any products rich in xanthine or grapefruit orally within 48 hours before administration;
- •Those who have participated in any clinical trials of drugs or medical devices within 3 months before screening (subject to administration).
- •The amount of blood donation (or blood loss) within 3 months before screening is ≥400 mL, or those who have received blood products to improve anemia;
- •One of ALT and/or AST >2*ULN, total bilirubin > 1.5* ULN and creatine kinase > 2*ULN during screening;
- •Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
- •Female subjects who are pregnant or lactating or whose serum pregnancy results are positive during the screening period or during the trial;
- •Subjects considered by the researcher to have any factors that are not suitable for participating in this trial.
研究组 & 干预措施
Mild Renal Impairment
Experimental
干预措施: HSK16149 (Drug)
Moderate Renal Impairment
Experimental
干预措施: HSK16149 (Drug)
Severe Renal Impairment
Experimental
干预措施: HSK16149 (Drug)
Normal Renal function
Experimental
干预措施: HSK16149 (Drug)
结局指标
主要结局
AUC0-inf
时间窗: From the start to 72 hours after administration
Area under the concentration-time curve from time zero extrapolated to infinite time
Cmax
时间窗: From the start to 72 hours after administration
The maximun plasma concentration of HSK16149
AUC0-t
时间窗: From the start to 72 hours after administration
Area under the concentration-time curve from time zero to time of last quantifiable concentration
次要结局
- Vz(From the start to 72 hours after administration)
- Ae(From the start to 72 hours after administration)
- Tmax(From the start to 72 hours after administration)
- CL(From the start to 72 hours after administration)
- Fe(From the start to 72 hours after administration)
- CLr(From the start to 72 hours after administration)
- t1/2(From the start to 72 hours after administration)
研究者
研究点 (1)
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