The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects
2020年7月23日 更新者：Sunshine Lake Pharma Co., Ltd.
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Litapiprant Tablets in Healthy Subjects
The Safety, Tolerability and Pharmacokinetic Study of Asthma Treatment Drug Litapiprant Tablets in Healthy Male and Female subjects.
研究概览
详细说明
This was a Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Litapiprant Tablets in Healthy Male and Female subjects.
A total of 60 healthy subjects were divided into 7 groups.
Group 1 consist of 4 subjects, 3 subjects will receive Litapiprant Tablets and 1 subject will receive placebo.Group 2,3,5,6 consist of 8 subjects respectively, in each group, 6 subjects will receive Litapiprant Tablets and 2 subjects will receive placebo.Group 4,7 consist of 12 subjects respectively, in each group, 10 subjects will receive Litapiprant Tablets and 2 subjects will receive placebo.
研究类型
介入性
注册 (实际的)
60
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
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Beijing
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Beijing、Beijing、中国、100038
- Beijing Shijitan Hospital
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-
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:
- Male or female, overall healthy subjects，female VS male 1:1 ratio;
- Between 18 and 45 years of age, inclusive, similar ages;
- Body weight should be≥50 kg; Body Mass Index (BMI) is between 19.0 and 28.0 kg/m2, inclusive;
- Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- Able to communicate well with the investigator and complete the study according to the protocol.
Exclusion Criteria:
- Pregnant or nursing female, or plan for pregnancy within 6 months;
- A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening;
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody， or HIV antibody . A clinically significant abnormal finding on HBV-DNA test ;
- Sitting systolic blood pressure (SBP) <90mmHg or >140mmHg, and/or sitting diastolic blood pressure (DBP) <60mmHg or >90mmHg at screening;
- With the history of using any drug which will inhibit or induce liver metabolize drug and/or will infect gastric acid within 1 month before randomization;
- Receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day;
- History of cardiovascular, immune system, Severe digestive system, Circulatory system, respiratory system, urinary system , nervous system,tumor diseases;
- Suffering from blood diseases such as coagulopathy;
- Patients with a history of mental illness or active mental illness;
- Have undergone major surgery within 6 months before enrollment;
- A history of gastrointestinal, liver ,kidney diseases likely to influence drug absorption within 6 months before enrollment;
- Drug or alcohol abuse;
- History of drug abuse and drug use within 1 year prior to the study;
- Habitual consumption of grapefruit juice, tea, coffee and/or caffeinated beverages, which cannot be withdrawn during the trial;
- The average daily smoking volume is >5 within 3 months prior to the study;
- A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study;
- Participation in a clinical study within 3 months of the first dose of study drug;
- Donation of blood within 3 months of the first dose of study drug or have a plan to donate blood;
- Cannot be tolerant to oral drugs;
- Poor peripheral venous access conditions;
- The investigator believes that it should not be included;
- Additional exclusion criteria apply.
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：治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：25mg single doses
Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
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|
安慰剂比较：50mg single doses
Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
安慰剂比较：100mg single doses
Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
安慰剂比较：200mg single doses
Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
安慰剂比较：400mg single doses
Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
安慰剂比较：600mg single doses
Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
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安慰剂比较：800mg single doses
Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
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 |
|---|---|---|
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Adverse events
大体时间：Baseline to day 8~10
|
To assess the safety and tolerability after a single dose of Litapiprant Tablets
|
Baseline to day 8~10
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
AUC0-∞
大体时间：Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
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area under the concentration versus time curve (AUC) from time zero to infinity
|
Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
|
AUC0-t
大体时间：Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
AUC from time zero to the time of the last quantifiable concentration time zero to the time of the last quantifiable concentration
|
Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
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Cmax
大体时间：Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
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maximum observed plasma concentration
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Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
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tmax
大体时间：Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
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time of the maximum observed plasma concentration
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Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
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t½
大体时间：Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
apparent terminal elimination half-life
|
Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
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Vz/F
大体时间：Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
apparent volume of distribution
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Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
|
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。
调查人员
- 首席研究员：Xinghe Wang, MD、Beijing Shijitan Hospital, Capital Medical University
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)
2018年10月25日
初级完成 (实际的)
2019年1月30日
研究完成 (实际的)
2019年1月30日
研究注册日期
首次提交
2018年9月2日
首先提交符合 QC 标准的
2018年9月6日
首次发布 (实际的)
2018年9月10日
研究记录更新
最后更新发布 (实际的)
2020年7月27日
上次提交的符合 QC 标准的更新
2020年7月23日
最后验证
2018年11月1日
更多信息
与本研究相关的术语
其他研究编号
- HEC46877-P-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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药物和器械信息、研究文件
研究美国 FDA 监管的药品
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研究美国 FDA 监管的设备产品
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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.
Litapiprant Tablet的临床试验
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University Hospital, Clermont-FerrandDr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501); Dr Gilles DUCHEIX (Attaché)(Clinical...完全的