Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean
Study Details
Study Description
Brief Summary
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Japanese_DWP14012 Amg DWP14012 Amg, tablets, orally, single and multiple administration |
Drug: DWP14012
DWP14012 tablets
Drug: Placebo
DWP14012 placebo-matching tablets
|
Experimental: Japanese_DWP14012 Bmg DWP14012 Bmg, tablets, orally, single and multiple administration |
Drug: DWP14012
DWP14012 tablets
Drug: Placebo
DWP14012 placebo-matching tablets
|
Experimental: Japanese_DWP14012 Cmg DWP14012 Cmg, tablets, orally, single and multiple administration |
Drug: DWP14012
DWP14012 tablets
Drug: Placebo
DWP14012 placebo-matching tablets
|
Experimental: Caucasian_DWP14012 Bmg DWP14012 Bmg, tablets, orally, single and multiple administration |
Drug: DWP14012
DWP14012 tablets
Drug: Placebo
DWP14012 placebo-matching tablets
|
Experimental: Caucasian_DWP14012 Cmg DWP14012 Cmg, tablets, orally, single and multiple administration |
Drug: DWP14012
DWP14012 tablets
Drug: Placebo
DWP14012 placebo-matching tablets
|
Experimental: Korean_DWP14012 Bmg DWP14012 Bmg, tablets, orally, single and multiple administration |
Drug: DWP14012
DWP14012 tablets
Drug: Placebo
DWP14012 placebo-matching tablets
|
Experimental: Korean_DWP14012 Cmg DWP14012 Cmg, tablets, orally, single and multiple administration |
Drug: DWP14012
DWP14012 tablets
Drug: Placebo
DWP14012 placebo-matching tablets
|
Placebo Comparator: Placebo DWP14012 placebo-matching tablets |
Drug: Placebo
DWP14012 placebo-matching tablets
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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 1]
After single administration of the investigational products, 24hr gastric pH monitoring started.
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWP14012004