Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean
- Registration Number
- NCT03574415
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Japanese_DWP14012 Amg Placebo DWP14012 Amg, tablets, orally, single and multiple administration Caucasian_DWP14012 Cmg Placebo DWP14012 Cmg, tablets, orally, single and multiple administration Korean_DWP14012 Bmg Placebo DWP14012 Bmg, tablets, orally, single and multiple administration Korean_DWP14012 Cmg Placebo DWP14012 Cmg, tablets, orally, single and multiple administration Japanese_DWP14012 Bmg Placebo DWP14012 Bmg, tablets, orally, single and multiple administration Japanese_DWP14012 Cmg Placebo DWP14012 Cmg, tablets, orally, single and multiple administration Placebo Placebo DWP14012 placebo-matching tablets Caucasian_DWP14012 Bmg Placebo DWP14012 Bmg, tablets, orally, single and multiple administration Caucasian_DWP14012 Cmg DWP14012 DWP14012 Cmg, tablets, orally, single and multiple administration Japanese_DWP14012 Cmg DWP14012 DWP14012 Cmg, tablets, orally, single and multiple administration Caucasian_DWP14012 Bmg DWP14012 DWP14012 Bmg, tablets, orally, single and multiple administration Korean_DWP14012 Cmg DWP14012 DWP14012 Cmg, tablets, orally, single and multiple administration Korean_DWP14012 Bmg DWP14012 DWP14012 Bmg, tablets, orally, single and multiple administration Japanese_DWP14012 Amg DWP14012 DWP14012 Amg, tablets, orally, single and multiple administration Japanese_DWP14012 Bmg DWP14012 DWP14012 Bmg, tablets, orally, single and multiple administration
- Primary Outcome Measures
Name Time Method Cmax,ss / Cmin,ss 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 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 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 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 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 Day 7 After single administration of the investigational products, 24hr gastric pH monitoring started.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of