NCT04414852Unknown1 期
A Multi-center, Non-randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetics of Apatinib Mesylate in Subjects With Impaired Renal Function and Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 主要终点
- Cmax
研究概览
简要总结
The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects with impaired renal function and healthy subjects, to give dose recommendations for patients with impaired 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
- Other
- 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
- •for subjects with impaired renal function
- •Able to comprehend and willing to sign an informed consent form (ICF)
- •18-70 years of age.
- •19 kg/m2<BMI <19-28 kg/m2
- •eGFR (MDRD equation) for mild impaired renal function: 60-89 mL/min/1.73 m2 eGFR (MDRD equation) for moderate impaired renal function: 30-59 mL/min/1.73 m2
- •In good health, except for kidney disease and complications, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
- •Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
- •for healthy subjects:
- •Able to comprehend and willing to sign an informed consent form (ICF)
- •18-70 years of age.
- •19 kg/m2<BMI <19-28 kg/m2
- •eGFR (MDRD equation) for mild impaired renal function: ≥90mL/min/1.73 m2
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
- •Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
排除标准
- •for subjects with renal impairment
- •Renal allograft recipients;
- •Need hemodialysis during study;
- •Uroclepsia or anuria;
- •Allergic to apatinib or ingredients;
- •History of heart disease in 12 months before study;
- •Coagulation disorders;
- •Hypertension and could not be controlled with hypotensor;
- •With hepatic or archenteric disease;
- •Participate in blood donation within 3 months before screening and donate blood volume ≥400mL, or receive blood transfusion, or donate blood volume≥200mL within 1 month prior dosing.
- •Take any clinical trial drugs within 3 months prior dosing;
- •Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days before dosing;
- •Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit = 285 mL of beer, or 100mL of wine), or take ≥5 cigarettes;
- •Positive in urine drug test;
- •Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
- •Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or grapefruit-containing products from 48 hours before dosing to the end of the study;
- •The investigator believes that the subjects are not eligible to participate in this trial.
- •for healthy subjects:
- •Renal allograft recipients;
- •Allergic to apatinib or ingredients;
- •History of heart disease in 12 months before study;
- •Coagulation disorders;
- •Hypertension and could not be controlled with hypotensor;
- •With hepatic or archenteric disease;
- •Participate in blood donation within 3 months before screening and donate blood volume ≥400mL, or receive blood transfusion, or donate blood volume≥200mL within 1 month prior dosing.
- •Take any clinical trial drugs within 3 months prior dosing;
- •Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days before dosing;
- •Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit =285 mL of beer, or 100mL of wine), or take ≥5 cigarettes;
- •Positive in urine drug test;
- •Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
- •Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or grapefruit-containing products from 48 hours before dosing to the end of the study;
- •The investigator believes that the subjects are not eligible to participate in this trial.
研究组 & 干预措施
mild renal impairment
Experimental
干预措施: Apatinib Mesylate (Drug)
normal renal impairment
Active Comparator
干预措施: Apatinib Mesylate (Drug)
moderate remal impairment
Experimental
干预措施: Apatinib Mesylate (Drug)
结局指标
主要结局
Cmax
时间窗: 0-96 hours
Maximum plasma concentration
AUC0-∞
时间窗: 0-96 hours
Area under the plasma concentration versus time curve from zero to infinity
AUC0-t
时间窗: 0-96 hours
Area under the plasma concentration versus time curve from zero to 96h
次要结局
未报告次要终点
研究者
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