A Rifampin Effect Study of SHR2554 on Healthy Chinese Adult Subjects
2020年10月6日 更新者:Jiangsu HengRui Medicine Co., Ltd.
A Single-center, Open, Single Does, Drug-drug Interaction Study to Investigate the Effects of Rifampin on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of SHR2554 Tablets
The primary objective of the study is to evaluate the effect of Rifampin on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single-dose oral administration of SHR2554 in healthy subjects.
研究概览
研究类型
介入性
注册 (实际的)
18
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Shanghai、中国
- Jiangsu HengRui Medicine Co., Ltd.
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- The informed consent is signed before the trial, and the content, process and possible adverse reactions are fully understood;
- Be able to complete the study according to the requirements of the test scheme;
- Healthy male and female subjects aged 18 to 45 years (including both ends) on the date of signing informed consent;
- The body weight of male subjects is no less than 50 kg and that of female subjects is no less than 45 kg. Body mass index (BMI) is in the range of 19.0-26.0 kg/m2 (including the critical value).
Exclusion Criteria:
- Participated in blood donation within 3 months before taking the study drug and donate blood ≥400 mL, or received blood transfusion;
- Allergic constitution, including severe drug allergy or drug allergy history; allergic history of SHR2554 tablets, Rifampin, Rifamycin or their excipients;
- People who have a history of drug and/or alcohol abuse, have a positive alcohol or drug screening test, or have a history of drug abuse in the past five years or have used drugs within 3 months before the test;
- Smoking and alcohol addicts (drinking 14 units of alcohol per week: 1 unit = 285 ml beer, 25 ml spirits, or 100 ml wine; smoking ≥ 5 cigarettes a day) and unable to prohibit smoking and alcohol during the test period;
- Comprehensive physical examination (vital signs, physical examination), routine laboratory examinations (blood routine, blood biochemistry, urine routine, etc.), 12-lead electrocardiogram, chest X-ray, heart color Doppler ultrasound, etc. are abnormal and have clinical significance as judged by the investigator;
- Echocardiography suggests that the left ventricular ejection fraction (LVEF) is less than 50% or the QT interval (QTcF) corrected by Fridericia method in 12-lead ECG is ≥ 470msec;
- A clear medical history of primary diseases of important organs such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system, etc., the investigator considers not suitable for participating in this study;
- Those who have undergone any surgery within 6 months before screening;
- Hepatotoxic drugs (such as Dapsone, Erythromycin, Fluconazole, Ketoconazole, Rifampin) have been taken for a long period of time (over 7 consecutive days) in the 6 months before screening;
- Those who have taken any clinical trial drugs within 3 months;
- Any drug that changes liver enzyme activity was taken within 28 days before taking the study drug;
- Any prescription or over-the-counter drugs taken within 14 days before taking the study drug;
- Ingested any vitamin products, health products or Chinese herbal medicine within 14 days before taking the study drug;
- HCV antibody positive, HIV antibody positive, HBsAg positive, syphilis antibody positive;
- Ingested grapefruit or products containing grapefruit, food or drink containing caffeine, xanthine or alcohol within 48 hours before taking the study drug; strenuous exercise, or other factors that affect the absorption, distribution, metabolism, and excretion of the study drug;
- The subjects have a childbearing plan and are unwilling to take effective contraceptive measures 2 weeks before the study administration (only female subjects) and 3 months after the last administration of the drug; those who are fertile and whose serum hCG test is not negative before the study medication;
- People with a history of fainting needles and blood, have difficulty in blood collection or cannot tolerate venipuncture blood collection;
- Women during pregnancy and lactation;
- Subjects with other factors not suitable to participate in this study as considered by the investigator.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:experimental group
Single-dose oral administration of SHR2554 and multiple-dose oral administration of Rifampin Capsules
|
Single-dose oral administration of SHR2554 and multiple-dose oral administration of Rifampin Capsules
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pharmacokinetics parameter: Cmax of SHR2554
大体时间:from Day 1 to Day 13
|
Peak Plasma Concentration (Cmax) of SHR2554
|
from Day 1 to Day 13
|
Pharmacokinetics parameter: AUC of SHR2554
大体时间:from Day 1 to Day 13
|
Area under the plasma concentration versus time curve (AUC) of SHR2554
|
from Day 1 to Day 13
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Other pharmacokinetics parameter: Tmax of SHR2554
大体时间:from Day 1 to Day 13
|
Time to maximum plasma concentration (Tmax) of SHR2554
|
from Day 1 to Day 13
|
Other pharmacokinetics parameter: T1/2 of SHR2554
大体时间:from Day 1 to Day 13
|
Half-life of elimination (T1/2) of SHR2554
|
from Day 1 to Day 13
|
The incidence and severity of adverse events/serious adverse events
大体时间:from Day 1 to Day 13
|
Based on NCI-CTC AE 5.0
|
from Day 1 to Day 13
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年5月28日
初级完成 (实际的)
2020年8月30日
研究完成 (实际的)
2020年9月20日
研究注册日期
首次提交
2020年9月24日
首先提交符合 QC 标准的
2020年10月6日
首次发布 (实际的)
2020年10月8日
研究记录更新
最后更新发布 (实际的)
2020年10月8日
上次提交的符合 QC 标准的更新
2020年10月6日
最后验证
2020年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SHR2554-I-107
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.