Phase I Study to Assess the Safety of APD-791 When Co-administered With Aspirin
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- To assess the safety of APD791 when orally co-administered with Aspirin and Clopidogrel in healthy subjects
研究概览
简要总结
Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel.
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
- All
- 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
- •a person who voluntarily decides to participate in this clinical trial and gives written consent on strict clinical trial compliance
- •a person whose blood can be collected during a study period with visit for monitoring
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
- •a person decided to be inappropriate to participate in this clinical trial according to investigator's medical decision on the result of laboratory tests, such as complete blood cell count, general chemical test, clinicochemical urinalysis, and physical examination, vital signs, ECG, other tests excluding exclusion criteria 17 items conducted before subject selection for a clinical trial
研究组 & 干预措施
60mg MD
APD791 60mg Multiple dose
干预措施: APD791 (Drug)
Placebo MD
Placebo for Multiple dose group
干预措施: Clopidogrel (Drug)
Placebo MD
Placebo for Multiple dose group
干预措施: Aspirin (Drug)
Placebo MD
Placebo for Multiple dose group
干预措施: APD791 (Drug)
120mg SD
APD791 120mg Single dose
干预措施: Clopidogrel (Drug)
120mg SD
APD791 120mg Single dose
干预措施: Aspirin (Drug)
120mg SD
APD791 120mg Single dose
干预措施: APD791 (Drug)
240mg SD
APD791 240mg Single dose
干预措施: Clopidogrel (Drug)
240mg SD
APD791 240mg Single dose
干预措施: Aspirin (Drug)
240mg SD
APD791 240mg Single dose
干预措施: APD791 (Drug)
320mg SD
APD791 320mg Single dose
干预措施: Clopidogrel (Drug)
60mg MD
APD791 60mg Multiple dose
干预措施: Clopidogrel (Drug)
60mg MD
APD791 60mg Multiple dose
干预措施: Aspirin (Drug)
10mg MD
APD791 10mg Multiple dose and
干预措施: Clopidogrel (Drug)
10mg MD
APD791 10mg Multiple dose and
干预措施: Aspirin (Drug)
10mg MD
APD791 10mg Multiple dose and
干预措施: APD791 (Drug)
20mg MD
APD791 20mg Multiple dose
干预措施: Clopidogrel (Drug)
20mg MD
APD791 20mg Multiple dose
干预措施: Aspirin (Drug)
20mg MD
APD791 20mg Multiple dose
干预措施: APD791 (Drug)
40mg MD
APD791 40mg Multiple dose
干预措施: Clopidogrel (Drug)
40mg MD
APD791 40mg Multiple dose
干预措施: Aspirin (Drug)
40mg MD
APD791 40mg Multiple dose
干预措施: APD791 (Drug)
320mg SD
APD791 320mg Single dose
干预措施: Aspirin (Drug)
320mg SD
APD791 320mg Single dose
干预措施: APD791 (Drug)
Placebo SD
Placebo for Single dose
干预措施: Clopidogrel (Drug)
Placebo SD
Placebo for Single dose
干预措施: Aspirin (Drug)
Placebo SD
Placebo for Single dose
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety of APD791 when orally co-administered with Aspirin and Clopidogrel in healthy subjects
时间窗: safety review will be conducted at every end of dosing (about every 2 or 3 weeks)
Adverse reaction monitoring for subjective or objective symptoms Physical examination Vital signs 12-electrode ECG Laboratory tests
次要结局
- Pharmacokinetic characteristic evaluation variable(After last patient last visit. About 8month later since start of the study.)
- Pharmacodynamic characteristic evaluation variable(Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.)