NCT01870674已完成1 期
A Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dose Phase 1 Clinical Study to Investigate the Safety/Tolerability and PK/PD of YH12852 After Oral Administration in Healthy Subjects
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- significant changes in vital sign
研究概览
简要总结
Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration 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
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male/female aged 19 to 45 with body mass index(BMI) between 18 and 25kg/m2
- •Subject who has no congenital, chronic disease and disease symptoms in medical examination result
- •Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead ECG etc)
- •Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
排除标准
- •Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
- •Subject who is hypersensitive to components contained in YH12852 or prucalopride or aspirin/antibiotics like drugs
- •Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
- •Clinically significant abnormal values in diagnostic check within 28 days before the treatment(>1.25 fold of normal upper limit in the levels of AST or ALT, >1.5 fold of normal upper limit in the levels of Total bilirubin, < 80ml/min of Cockcroft-Gault used creatinine clearance
- •Subject has over QTc interval of 550 ms or PR interval of 210 ms or QRS interval of 120 ms or QT interval of 500 ms on baseline 12-lead ECG, as determined by the Investigator
- •Subject who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment
- •Subject who participated in another clinical trail within 2 months before enrolling in this study
- •subject who donated whole blood within 2 months or component blood within 1 month before the treatment
- •Medically unacceptable contraception used during the clinical trial
- •Subject who drank over 30g/day or were detected alcohol positive on test
- •Subject who stopped smoking within 3 months before the treatment or weren't able to stop smoking during the hospitalization
- •Subject who had a beverage containing caffeine during the hospitalization
- •Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
研究组 & 干预措施
YH12852
Experimental
<SAD cohort>
- Experimental: YH12852 1mg/single dose, qd
- Experimental: YH12852 3mg/single dose, qd
- Experimental: YH12852 10mg/single dose, qd
<FSD cohort>
- Experimental: YH12852 0.5mg/single dose, qd
- Experimental: YH12852 1mg/single dose, qd
- Experimental: YH12852 2mg/single dose, qd
- Experimental: YH12852 3mg/single dose, qd
<MAD cohort>
-
Experimental: YH12852 0.5mg/repeat dose, qd
-
Experimental: YH12852 1mg/repeat dose, qd
-
Experimental: YH12852 2mg/repeat dose, qd
-
Experimental: YH12852 3mg/repeat dose, qd
-
Each dosing group(except MAD cohort 0.5mg which has single treatment arm taking YH12852 only) contains 12 subjects. 12 subjects are administered YH12852 or placebo/active comparators.(YH12852:placebo:active=8:2:2)
干预措施: YH12852 (Drug)
Prucalopride
Active Comparator
<each cohort> Prucalopride succinate 1.321mg
干预措施: Prucalopride (Drug)
Placebo
Placebo Comparator
<each cohort> Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
significant changes in vital sign
时间窗: D1~Post study visit
the number of adverse events, seriousness of adverse event
时间窗: D1~Post study visit
significant physical exam
时间窗: D1~Post study visit
significant changes in 12-lead electrocardiography
时间窗: D1~Post study visit
significant changes in laboratory test
时间窗: D1~Post study visit
次要结局
- AUC(0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort))
- BSFS(D1~7(SAD, FSD cohorts), D1~14(MAD cohort))
- Cmax(0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort))
- Ae(0~48 hrs(SAD cohort), 0~24 hrs/D7 0~48hrs(MAD cohort))
- Frequency of defecation(D1~7(SAD, FSD cohorts), D1~14(MAD cohort))
研究者
研究点 (1)
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