Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
2017年7月6日 更新者:Chong Kun Dang Pharmaceutical
A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult Volunteers : Part I- Single Dosing / Part II- Multiple Dosing
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519
研究概览
详细说明
A randomized, double-blind, placebo-controlled, phase I clinical trial to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519 after oral administration in healthy adult volunteers Part I- single dosing / Part II- multiple dosing
研究类型
介入性
注册 (实际的)
18
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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Seodaemun-gu
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Seoul、Seodaemun-gu、大韩民国、120-752
- Severance 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
19年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Between 19 aged and 55 aged in healthy adult
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
If female, must include more than one among the items
- The menopause(there is no natural menses for at least 2 years)
- Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
- Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent
Exclusion Criteria:
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
- Have a history of Toresades de pointes(TdP) or additional risk factors for Toresades de pointes(TdP). (Family history of long QT syndrome or sudden death, heart failure, hypokalemia, etc)
- Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
- An impossible one who participates in clinical trial including screening tests(medical history taking, BP, 12-lead ECG, physical examination, blood&urine laboratory test result) before 28 days the taking investigational Products.
Defined by the following laboratory parameters
- AST, ALT>1.25 upper limit of normal range
- Total bilirubin>1.5 upper limit of normal range
- CPK>1.5 upper limit of normal range
- eGFR(using by MDRD method)<60mL/min/1.73m2
Defined by the following 12-lead ECG
- HR<40 or >110bpm
- PR interval>220ms or ≤110ms
- QRS interval>120ms
- QTcF<300ms or >450ms
- Pathologic Q-waves (defined as >40ms or depth>0.5mV)
- Incomplete or complete bundle branch block
- Pre-excitation (e.g., Wolfe-Parkinson-White Syndrome)
- Atrial fibrillation/flutter
- Second- or third-degree atrioventricular (AV)block
- Investigator judges to be unfavorable for consistently accurate QT measurements(e.g., indistinct QRS onset, low amplitude T wave, inverted or terminally inverted T wave, merged T/U waves, indistinct T wave offset , or prominent U wave that affects QT measurement)
- Sitting SBP>150mmHg or <90mmHg, sitting DBP>100mmHg or <50mmHg, after 5 minutes break.
- Drug abuse or have a history of drug abuse shows a positive for urine drug test.
- Pregnant or lactating women.
- A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer (alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
- Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects.
- Subject who takes inhibitor and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30 days.
- Taking concomitant medications that prolong the QT/QTc interval within 14 days before the beginning of study treatment.
- Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7days before the beginning of study treatment)
- Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
- Previously donate whole blood within 60 days or component blood within 30 days.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- Positive for Serology test(Hepatitis B, Hepatitis C, HIV)
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:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:CKD-519 400mg(PartⅠ: 1day)
CKD-519 400mg(100mg x 4tabs) or placebo
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Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14
Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14
|
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实验性的:CKD-519 400mg(PartⅡ: 14days)
CKD-519 400mg(100mg x 4tabs) or placebo
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Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14
Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14
|
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 |
|---|---|---|
|
Maximum Plasma Concentration [Cmax] of CKD-519
大体时间:Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
Pharmacokinetics after administration of single and multiple doses
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Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacodynamics(Lipid Parameter) of CKD-519
大体时间:PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21
|
simultaneous with laboratory test after multiple administration
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PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21
|
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Pharmacodynamics(CETP) of CKD-519
大体时间:Day1: 0(predose)~168hour
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Pharmacodynamics after administration of single and multiple doses
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Day1: 0(predose)~168hour
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Pharmacodynamics(QC/QTc) of CKD-519
大体时间:Part II - Day-1, Day 1, Day14
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Pharmacokinetics after multiple administration
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Part II - Day-1, Day 1, Day14
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Curve [AUC] [Cmax] of CKD-519
大体时间:Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
Pharmacokinetics after administration of single and multiple
|
Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
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)
2017年3月7日
初级完成 (实际的)
2017年4月24日
研究完成 (实际的)
2017年4月24日
研究注册日期
首次提交
2017年6月2日
首先提交符合 QC 标准的
2017年7月6日
首次发布 (实际的)
2017年7月7日
研究记录更新
最后更新发布 (实际的)
2017年7月7日
上次提交的符合 QC 标准的更新
2017年7月6日
最后验证
2017年7月1日
更多信息
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