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临床试验/NCT02419820
NCT02419820终止1 期

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

IlDong Pharmaceutical Co Ltd0 个研究点目标入组 104 人开始时间: 2015年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
104
主要终点
Pharmacokinetics-Tmax
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years（Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •a healthy adult between 20 and 45 years old at the time of visit for screening
  • •a person who is able to give written consent
  • •a person between 50 and 85 kg at the time of visit for screening
  • •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
  • •a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
  • •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

排除标准

  • •a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
  • •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
  • •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
  • •a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
  • •a person with the medical history of epilepsy or convulsion
  • •a person with the medical history of internal organ transplant
  • •a person expected to be hard to complete a clinical trial because of surgery or medical procedures planned within a clinical trial period
  • •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
  • •a person with hypersensitivity reaction to a drug or gelatin, or the medical history of clinically significant hypersensitivity reaction
  • •a person with the history of drug abuse, or with a positive reaction to a drug possible to be abused on urine drug screening
  • •a person with the medical history of alcohol abuse within two years from the time of visit for screening
  • •a person who is a smoker, or with a positive reaction on a urine nicotine test conducted at the time of visit for screening
  • •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
  • •a person taking other clinical trial drugs within 90 days from the time of visit for screening
  • •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
  • •a person with a positive reaction to a serum test(hepatitis B test, hepatitis C test, HIV test, syphilis test)
  • •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)
  • •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

研究组 & 干预措施

APD791 placebo MD

Placebo Comparator

APD791 placebo for multiple dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 10mg single dose

Experimental

APD791 10mg single dose

干预措施: APD791 (Drug)

APD791 placebo MD

Placebo Comparator

APD791 placebo for multiple dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 20mg single dose

Experimental

APD791 20mg single dose

干预措施: APD791 (Drug)

APD791 40mg single dose

Experimental

APD791 40mg single dose

干预措施: APD791 (Drug)

APD791 10mg

Experimental

APD791 10mg single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 10mg

Experimental

APD791 10mg single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 10mg

Experimental

APD791 10mg single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 20mg

Experimental

APD791 20mg single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 20mg

Experimental

APD791 20mg single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 20mg

Experimental

APD791 20mg single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 40mg

Experimental

APD791 40mg single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 40mg

Experimental

APD791 40mg single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 40mg

Experimental

APD791 40mg single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 80mg

Experimental

APD791 80mg single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 80mg

Experimental

APD791 80mg single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 80mg

Experimental

APD791 80mg single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 160mg

Experimental

APD791 160mg single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 160mg

Experimental

APD791 160mg single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 160mg

Experimental

APD791 160mg single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 240mg

Experimental

APD791 240mg single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 240mg

Experimental

APD791 240mg single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 240mg

Experimental

APD791 240mg single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 320mg

Experimental

APD791 320mg single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 320mg

Experimental

APD791 320mg single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 320mg

Experimental

APD791 320mg single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 Placebo

Placebo Comparator

APD791 placebo for single dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 Placebo

Placebo Comparator

APD791 placebo for single dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 Placebo

Placebo Comparator

APD791 placebo for single dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 Placebo

Placebo Comparator

APD791 placebo for single dose + Aspirin + Clopidogrel

干预措施: Placebo for APD791 (Drug)

APD791 2mg MD

Experimental

APD791 2mg multiple dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 2mg MD

Experimental

APD791 2mg multiple dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 2mg MD

Experimental

APD791 2mg multiple dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 5mg MD

Experimental

APD791 5mg multiple dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 5mg MD

Experimental

APD791 5mg multiple dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 5mg MD

Experimental

APD791 5mg multiple dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 10mg MD

Experimental

APD791 10mg multiple dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 10mg MD

Experimental

APD791 10mg multiple dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 10mg MD

Experimental

APD791 10mg multiple dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 20mg MD

Experimental

APD791 placebo for multiple dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 20mg MD

Experimental

APD791 placebo for multiple dose + Aspirin + Clopidogrel

干预措施: Clopidogrel (Drug)

APD791 20mg MD

Experimental

APD791 placebo for multiple dose + Aspirin + Clopidogrel

干预措施: Aspirin (Drug)

APD791 placebo MD

Placebo Comparator

APD791 placebo for multiple dose + Aspirin + Clopidogrel

干预措施: APD791 (Drug)

APD791 placebo MD

Placebo Comparator

APD791 placebo for multiple dose + Aspirin + Clopidogrel

干预措施: Placebo for APD791 (Drug)

结局指标

主要结局

Pharmacokinetics-Tmax

时间窗: Day1, Day2, Day3, Day4, Day 7

Pharmacokinetics-Cmax

时间窗: Day1, Day2, Day3, Day4, Day 7

Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation

时间窗: Day1, Day2, Day4, Day7, Day 8

Pharmacodynamics-change of serotonin-stimulated platelet aggregation

时间窗: Day1, Day4, Day7

Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation

时间窗: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.

次要结局

  • adverse event monitoring(up to post-study visit(8day±2))
  • physical examination(up to post-study visit(8day±2))
  • vital signs(up to post-study visit(8day±2))
  • ECG(up to post-study visit(8day±2))
  • laboratory test(up to post-study visit(8day±2))

研究者

申办方类型
Industry
责任方
Sponsor

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