NCT01522586终止1 期
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2012年1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
- 终止
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Safety&tolerability
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Healthy adult male subjects aged 20 to 45 years
- •The subject has Broca's index ≤ 20%
- •A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
排除标准
- •A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- •A subject who shows vital signs with the number of systolic blood pressure of ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg
- •A subject who shows the following result in clinical laboratory test:
- •AST,ALT>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min
- •Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).
研究组 & 干预措施
DWP09031
Experimental
DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
干预措施: DWP09031 (Drug)
Placebo
Placebo Comparator
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Safety&tolerability
时间窗: -1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit)
Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)
次要结局
- Pharmacokinetics(0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h)
研究者
研究点 (1)
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