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Dose-escalation, Repeated and Single Oral Dosing Study

2019年2月11日 更新者:IlDong Pharmaceutical Co Ltd

Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Temanogrel Co-administered With Aspirin and Clopidogrel

Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791 (Temanogrel) Co-administered with Aspirin and Clopidogrel.

研究概览

详细说明

  1. To investigate pharmacokinetic and pharmacodynamic characteristics of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subject. a person determined to be suitable for the purpose of this clinical trial by investigator with consideration for the age and the health status of a volunteer is selected
  2. Assess the safety of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subjects.

研究类型

介入性

注册 (实际的)

104

阶段

  • 阶段1

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

20年 至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. a healthy adult between 20 and 45 years old at the time of visit for screening
  2. a person who is able to give written consent
  3. a person between 50 and 85 kg at the time of visit for screening
  4. a woman who is negative on a serum hCG test at the time of visit and the day before a trial, and who is not nursing, a woman who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, or who had a contraceptive operation no later than 120 days before visit for screening, or who is menopausal, a man who had a contraceptive operation no later than 120 days before visit for screening, or who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, and also agree not to donate sperm
  5. a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
  6. a person whose vital signs were in the normal range at the time of visit for screening, or who is medically determined not to be clinically significant by an investigator

Exclusion Criteria:

  1. a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
  2. a person with the medical history of gastrointestinal diseases(e.g. Crohn's disease, ulcerative colitis, etc.) or surgery(excluding uncomplicated appendectomy or herniotomy) affecting the absorption of a clinical trial drug
  3. a person with the medical history of blood coagulation disorder or hemorrhagic diseases, or with clinically significant abnormal findings decided by a investigator on blood coagulation test at the time of screening
  4. a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
  5. a person with the medical history of epilepsy or convulsion
  6. a person with the medical history of internal organ transplant
  7. a person expected to be hard to complete a clinical trial because of surgery or medical procedures planned within a clinical trial period
  8. a person with the medical history of clinically significant new diseases within 30 days from the time of visit for screening according to investigator's decision
  9. a person with hypersensitivity reaction to a drug or gelatin, or the medical history of clinically significant hypersensitivity reaction
  10. a person with the history of drug abuse, or with a positive reaction to a drug possible to be abused on urine drug screening
  11. a person with the medical history of alcohol abuse within two years from the time of visit for screening
  12. a person who is a smoker, or with a positive reaction on a urine nicotine test conducted at the time of visit for screening
  13. a person who donated whole blood within 60 days or constituents of blood within 30 days, or received a blood transfusion within 30 days from the time of visit for screening
  14. a person taking other clinical trial drugs within 90 days from the time of visit for screening
  15. a person taking a prescription drug within 30 days, or a contraindicated drug or oriental medicine within 14 days from the time of visit for screening
  16. a person with a positive reaction to a serum test(hepatitis B test, hepatitis C test, HIV test, syphilis test)
  17. a person with hepatic enzymes(AST, ALT) more than 2.5 times of the reference upper limit(UNL) or total bilirubin more than 1.5 times of the reference upper limit(UNL) or creatinine more than 1.25 times of the reference upper limit(UNL)
  18. a person expected to be hard to complete a clinical trial due to physical or mental status according to investigator's medical decision at the time of visit for screening

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:放映
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:APD791 10mg single dose
Temanogrel
其他名称:
  • Temanogrel
实验性的:APD791 20mg single dose
Temanogrel
其他名称:
  • Temanogrel
实验性的:APD791 40mg single dose
Temanogrel
其他名称:
  • Temanogrel
实验性的:APD791 10mg
APD791 10mg single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 20mg
APD791 20mg single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 40mg
APD791 40mg single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 80mg
APD791 80mg single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 160mg
APD791 160mg single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 240mg
APD791 240mg single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 320mg
APD791 320mg single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
安慰剂比较:APD791 Placebo
APD791 placebo for single dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
Placebo for APD791
其他名称:
  • Placebo for Temanogrel
实验性的:APD791 2mg MD
APD791 2mg multiple dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 5mg MD
APD791 5mg multiple dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 10mg MD
APD791 10mg multiple dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
实验性的:APD791 20mg MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
安慰剂比较:APD791 placebo MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
氯吡格雷
其他名称:
  • 波立维
Temanogrel
其他名称:
  • Temanogrel
阿司匹林
其他名称:
  • 阿司匹林保护
Placebo for APD791
其他名称:
  • Placebo for Temanogrel

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Pharmacokinetics-Cmax
大体时间:Day1, Day2, Day3, Day4, Day 7
Day1, Day2, Day3, Day4, Day 7
Pharmacokinetics-Tmax
大体时间:Day1, Day2, Day3, Day4, Day 7
Day1, Day2, Day3, Day4, Day 7
Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation
大体时间:Day1, Day2, Day4, Day7, Day 8
Day1, Day2, Day4, Day7, Day 8
Pharmacodynamics-change of serotonin-stimulated platelet aggregation
大体时间:Day1, Day4, Day7
Day1, Day4, Day7
Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation
大体时间:Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.
Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.

次要结果测量

结果测量
大体时间
adverse event monitoring
大体时间:up to post-study visit(8day±2)
up to post-study visit(8day±2)
physical examination
大体时间:up to post-study visit(8day±2)
up to post-study visit(8day±2)
vital signs
大体时间:up to post-study visit(8day±2)
up to post-study visit(8day±2)
ECG
大体时间:up to post-study visit(8day±2)
up to post-study visit(8day±2)
laboratory test
大体时间:up to post-study visit(8day±2)
up to post-study visit(8day±2)

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:Gyunseop Bae, M.D.、Asan Medical Center

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)

2015年3月1日

初级完成 (实际的)

2016年4月1日

研究完成 (实际的)

2016年4月1日

研究注册日期

首次提交

2015年1月27日

首先提交符合 QC 标准的

2015年4月16日

首次发布 (估计)

2015年4月17日

研究记录更新

最后更新发布 (实际的)

2019年2月15日

上次提交的符合 QC 标准的更新

2019年2月11日

最后验证

2019年2月1日

更多信息

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.

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