The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
2020年3月17日 更新者:Sunshine Lake Pharma Co., Ltd.
A Phase I, Single-center, Randomized,Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
研究概览
详细说明
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.
研究类型
介入性
注册 (实际的)
105
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
-
-
Jilin
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Changchun、Jilin、中国、130021
- The First Hospital of Jilin University
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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:
- Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- Able to complete the study according to the protocol;
- Between 18 and 45 years of age, inclusive, male subject should be no fertility needs;
- Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2, inclusive;
- Physical examination and vital signs without clinically significant abnormalities.
Exclusion Criteria:
- Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
- Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- Donated blood or massive blood loss within 3 months before screening (>450 mL);
- Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
- Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening;
- Have participated in any clinical trial or taken any study drug within 3 months before dosing;
- Viral hepatitis(including CHB and CHC)and positive test result of anti-HIV Ab or syphilis.
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 |
|---|---|
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实验性的:50 mg single dose
It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) .
Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
|
匹配的安慰剂胶囊
Capsule administered orally once daily
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实验性的:100 mg single dose
Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
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匹配的安慰剂胶囊
Capsule administered orally once daily
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实验性的:200 mg single dose
Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.
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匹配的安慰剂胶囊
Capsule administered orally once daily
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实验性的:400 mg single dose
Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
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匹配的安慰剂胶囊
Capsule administered orally once daily
|
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实验性的:600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
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匹配的安慰剂胶囊
Capsule administered orally once daily
|
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实验性的:800 mg single dose
Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
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匹配的安慰剂胶囊
Capsule administered orally once daily
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实验性的:100 mg multiple doses
Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
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匹配的安慰剂胶囊
Capsule administered orally once daily
|
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实验性的:200 mg multiple doses
Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
|
匹配的安慰剂胶囊
Capsule administered orally once daily
|
|
实验性的:400 mg multiple doses
Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
|
匹配的安慰剂胶囊
Capsule administered orally once daily
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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 of the single ascending-dose
大体时间:Baseline to day 6~13
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To assess the tolerability after a single dose of HEC74647PA capsule
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Baseline to day 6~13
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Adverse events of the multiple ascending-dose
大体时间:Baseline to day 12
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To assess the tolerability after multiple doses of HEC74647PA capsule
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Baseline to day 12
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Tmax
大体时间:Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Time of the maximum observed plasma concentration
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Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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AUC
大体时间:Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Area under the plasma concentration-time curve (AUC)
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Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Cmax
大体时间:Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Maximum observed plasma concentration of HEC74647
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Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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T1/2
大体时间:Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Terminal elimination half-life
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Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Vz/F
大体时间:Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Apparent volume of distribution
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Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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CL/F
大体时间:Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Oral clearance
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Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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MRT
大体时间:Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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Mean Residence Time
|
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
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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)
2018年9月4日
初级完成 (实际的)
2019年7月2日
研究完成 (实际的)
2019年7月5日
研究注册日期
首次提交
2018年9月10日
首先提交符合 QC 标准的
2018年9月13日
首次发布 (实际的)
2018年9月17日
研究记录更新
最后更新发布 (实际的)
2020年3月19日
上次提交的符合 QC 标准的更新
2020年3月17日
最后验证
2018年9月1日
更多信息
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