A Randomized, Open-label, Placebo- and Active- Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration 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
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males aged between 19 and 50 at screening
- •Weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
- •Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
排除标准
- •Subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- •Subject has gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- •Subject has been Helicobacter pylori positive
- •AST (SGOT) and ALT (SGPT) > 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- •Subject has anatomical disability in insertion and maintenance of pH meter catheter
研究组 & 干预措施
Cohort 1
Single-ascending cohort 1
干预措施: Cohort 1 (JP-1366 A mg) (Drug)
Cohort 2
Single-ascending cohort 2
干预措施: Cohort 2 (JP-1366 B mg) (Drug)
Cohort 3
Single-ascending cohort 3
干预措施: Cohort 3 (JP-1366 C mg) (Drug)
Cohort 4
Single-ascending cohort 4
干预措施: Cohort 4 (JP-1366 D mg) (Drug)
Cohort 5
Single-ascending cohort 5
干预措施: Cohort 5 (JP-1366 E mg) (Drug)
Cohort 6
Multiple-ascending cohort 1
干预措施: Cohort 6 (JP-1366 F mg) (Drug)
Cohort 7
Multiple-ascending cohort 2
干预措施: Cohort 7 (JP-1366 G mg) (Drug)
Cohort 8
Multiple-ascending cohort 3
干预措施: Cohort 8 (JP-1366 H mg) (Drug)
Cohort 9
Multiple-ascending cohort 4
干预措施: Cohort 9 (JP-1366 I mg) (Drug)
结局指标
主要结局
Cmax
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
AUClast
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
AUCinf
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
tmax
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
t1/2
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
Cmax,ss
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
Cmin,ss
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
Cav,ss
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
AUCτ
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
tmax,ss
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
Percentage of total time that the intragastric pH was above 4
时间窗: 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7)
MAD
Serum gastrin concentration
时间窗: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24h post-dose, Day 4 pre-dose, Day 6 pre-dose, Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose
MAD
次要结局
未报告次要终点