A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dose, Dose-escalation Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 After Oral Administration in Healthy Male Subjects, Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of CJ-12406
研究概览
简要总结
Study objectives
- To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CJ-12406 in healthy male subjects.
- To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to healthy male subjects.
- To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406 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
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Subjects with no history of any significant chronic disease
- •The weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- •Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
- •Available for the entire study period
- •Willing to adhere to protocol requirements and sign a informed consent form
- •Multiple escalation study; H. pylori positive, as determined by the urea breath test
排除标准
- •History of clinically significant allergies including drug allergies
- •History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
- •Symptom of an acute illness within 4 weeks prior to drug administration
- •History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
- •Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration
- •Clinical laboratory test values are outside the accepted normal range
- •AST or ALT >1.25 times to normal range
- •Creatinine clearance <80 mL/min
- •12-lead ECG; PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec
- •Clinically significant vital signs
- •Hypotension (SBP ≤ 89 mmHg)
- •Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg)
- •Tachycardia (≥ 101 beats/min)
- •History of drug and alcohol abuse(alcohol > 30 g/day)
- •Subjects who have ever smoke within 3 months prior to drug administration
- •Positive urine screen for drugs and cotinine
- •Use of any other medication, including herbal products, within the 2 weeks before dosing
- •Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
- •Donated blood within 60 days prior to dosing
- •Participated in a previous clinical trial within 90 days prior to dosing
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
CJ-12406
CJ-12406 Tablet, daily for 1 day or bid for 10 days
干预措施: CJ-12406 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of CJ-12406
时间窗: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.
Number of participants with adverse events
时间窗: A range of 17 days - from screening to gollow-up visit
Peak plasma concentration (Cmax) of CJ-12406
时间窗: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.
Area under the plasma concentration versus time curve (AUC) of active metabolite
时间窗: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.
Peak plasma concentration (Cmax) of active metabolite
时间窗: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.
次要结局
- H. pylori eradication rate(38 days post dose (plus of minus 1 day))
- The percent time of intragastric pH>4(7 days post dose)