Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: DWP14012
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Japanese_DWP14012 Amg<br>DWP14012 Amg, tablets, orally, single and multiple administration | Drug: DWP14012<br>* DWP14012 tablets<br>Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|
| Experimental: Japanese_DWP14012 Bmg<br>DWP14012 Bmg, tablets, orally, single and multiple administration | Drug: DWP14012<br>* DWP14012 tablets<br>Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|
| Experimental: Japanese_DWP14012 Cmg<br>DWP14012 Cmg, tablets, orally, single and multiple administration | Drug: DWP14012<br>* DWP14012 tablets<br>Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|
| Experimental: Caucasian_DWP14012 Bmg<br>DWP14012 Bmg, tablets, orally, single and multiple administration | Drug: DWP14012<br>* DWP14012 tablets<br>Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|
| Experimental: Caucasian_DWP14012 Cmg<br>DWP14012 Cmg, tablets, orally, single and multiple administration | Drug: DWP14012<br>* DWP14012 tablets<br>Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|
| Experimental: Korean_DWP14012 Bmg<br>DWP14012 Bmg, tablets, orally, single and multiple administration | Drug: DWP14012<br>* DWP14012 tablets<br>Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|
| Experimental: Korean_DWP14012 Cmg<br>DWP14012 Cmg, tablets, orally, single and multiple administration | Drug: DWP14012<br>* DWP14012 tablets<br>Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|
| Placebo Comparator: Placebo<br>DWP14012 placebo-matching tablets | Drug: Placebo<br>* DWP14012 placebo-matching tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration of DWP14012 | 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 | 
| Cmax,ss / Cmin,ss | Maximum / Minimum concentration of DWP14012 at steady state | 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 | 
| Tmax | Time of maximum concentration | 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 | 
| AUClast / AUCinf | Area under the plasma concentration-time curve | 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 | 
| T1/2 | Elimination half-life | 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 | 
| Percentage of total time that the intragastric pH was above 4 | After single administration of the investigational products, 24hr gastric pH monitoring started. | Day 1 | 
| Percentage of total time that the intragastric pH was above 4 | After single administration of the investigational products, 24hr gastric pH monitoring started. | Day 7 |