A Single-center, Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP14012 in Healthy Japanese, Caucasian and Korean
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cmax,ss / Cmin,ss
研究概览
简要总结
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean 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
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
- •Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
排除标准
- •Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- •Those who have 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)
- •Those who have been Helicobacter pylori positive
- •Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- •Those who have anatomical disability in insertion and maintenance of pH meter catheter
研究组 & 干预措施
Caucasian_DWP14012 Cmg
DWP14012 Cmg, tablets, orally, single and multiple administration
干预措施: Placebo (Drug)
Korean_DWP14012 Bmg
DWP14012 Bmg, tablets, orally, single and multiple administration
干预措施: DWP14012 (Drug)
Japanese_DWP14012 Amg
DWP14012 Amg, tablets, orally, single and multiple administration
干预措施: DWP14012 (Drug)
Japanese_DWP14012 Amg
DWP14012 Amg, tablets, orally, single and multiple administration
干预措施: Placebo (Drug)
Japanese_DWP14012 Bmg
DWP14012 Bmg, tablets, orally, single and multiple administration
干预措施: DWP14012 (Drug)
Japanese_DWP14012 Bmg
DWP14012 Bmg, tablets, orally, single and multiple administration
干预措施: Placebo (Drug)
Japanese_DWP14012 Cmg
DWP14012 Cmg, tablets, orally, single and multiple administration
干预措施: DWP14012 (Drug)
Japanese_DWP14012 Cmg
DWP14012 Cmg, tablets, orally, single and multiple administration
干预措施: Placebo (Drug)
Caucasian_DWP14012 Bmg
DWP14012 Bmg, tablets, orally, single and multiple administration
干预措施: DWP14012 (Drug)
Caucasian_DWP14012 Bmg
DWP14012 Bmg, tablets, orally, single and multiple administration
干预措施: Placebo (Drug)
Caucasian_DWP14012 Cmg
DWP14012 Cmg, tablets, orally, single and multiple administration
干预措施: DWP14012 (Drug)
Korean_DWP14012 Bmg
DWP14012 Bmg, tablets, orally, single and multiple administration
干预措施: Placebo (Drug)
Korean_DWP14012 Cmg
DWP14012 Cmg, tablets, orally, single and multiple administration
干预措施: DWP14012 (Drug)
Korean_DWP14012 Cmg
DWP14012 Cmg, tablets, orally, single and multiple administration
干预措施: Placebo (Drug)
Placebo
DWP14012 placebo-matching tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax,ss / Cmin,ss
时间窗: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Maximum / Minimum concentration of DWP14012 at steady state
Tmax
时间窗: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Time of maximum concentration
AUClast / AUCinf
时间窗: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Area under the plasma concentration-time curve
Cmax
时间窗: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Maximum concentration of DWP14012
T1/2
时间窗: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Elimination half-life
Percentage of total time that the intragastric pH was above 4
时间窗: Day 7
After single administration of the investigational products, 24hr gastric pH monitoring started.
次要结局
未报告次要终点