NCT01473173已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study, to Investigate the Safety, Tolerability, PK and PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects
研究概览
简要总结
The objectives of this study are:
- To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.
- To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.
- To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.
- To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male 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
- 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
- •Male volunteers in the age between 20 and 45 years old (inclusive)
- •Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg
- •Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 140 mmHg, 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg, 45 beats per minute ≤ pulse rate ≤ 95 beats per minute)
- •Non-smokers or non-users of nicotine-containing products for at least 3 months
排除标准
- •History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- •History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
- •History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
研究组 & 干预措施
CJ-12420 50mg
Experimental
- Single dose
- 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2)
干预措施: CJ-12420 (Drug)
CJ-12420 100mg
Experimental
- Single dose
- 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2)
干预措施: CJ-12420 (Drug)
CJ-12420 200mg
Experimental
- Single dose
- 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2)
干预措施: CJ-12420 (Drug)
CJ-12420 400mg
Experimental
- Single dose
- 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2)
干预措施: CJ-12420 (Drug)
CJ-12420 100mg (repeated dose)
Experimental
Repeat doses
- 100mg is the anticipated dose
- 8 volunteers will be administered CJ-12420 100mg or placebo comparator.(CJ-12420:placebo=6:2)
干预措施: CJ-12420 (Drug)
CJ-12420 200mg (repeated dose)
Experimental
Repeat doses
- 200mg is the anticipated dose
- 8 volunteers will be administered CJ-12420 200mg or placebo comparator.(CJ-12420:placebo=6:2)
干预措施: CJ-12420 (Drug)
Esomeprazole 40mg
Active Comparator
8 volunteers will be administered Esomeprazole 40mg
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects
时间窗: Throughout the study
次要结局
未报告次要终点
研究者
研究点 (1)
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