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This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: DWP14012 Amg | Experimental | DWP14012 Amg, tablets, orally, single dose administration |
|
| Cohort 2: DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, single dose administration |
|
| Cohort 3: DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single dose administration |
|
| Cohort 4: DWP14012 Dmg | Experimental | DWP14012 Dmg, tablets, orally, single dose administration |
|
| Cohort 5: DWP14012 Emg | Experimental | DWP14012 Emg, tablets, orally, single dose administration |
|
| Cohort 6: DWP14012 Fmg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 | Drug | DWP14012 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of Participants With Adverse Events (AE) | All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate adn severe. | Day -2(Randomization) to Day 11~18(Post-study visit) |
| Number and percentage of Participants With Adverse Drug Reactions (ADR) | An adverse drug reaction (ADR) is an injury caused by taking an investigational product. | Day -2(Randomization) to Day 11~18(Post-study visit) |
| Number of Participants With Clinically Significant Vital Sign findings | Blood pressure, pulse and body temperature were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability. | Day -2(Randomization) to Day 11~18(Post-study visit) |
| Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings | Ventricular rate, RR interval, PR interval, QRS duration, QTcB and QTcF were recorded. The results of 12-lead ECG will be categorized Normal/Abnormal NCS(No clinically significant)/Abnormal CS(clinically significant). | Day -2(Randomization) to Day 11~18(Post-study visit) |
| Number of Participants With Clinically Significant Laboratory results | Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability. | Day -2(Randomization) to Day 11~18(Post-study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum concentration of DWP14012 | in single ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| Cmax,ss: Maximum concentration of DWP14012 at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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DWP14012 Emg, tablets, orally, single dose administration
|
| Cohort 1-6: Placebo | Placebo Comparator | DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, single dose administration |
|
| Cohort 1-6: Esomeprazole | Active Comparator | Nexium® tablets, orally, single dose administration |
|
| Cohort 7: DWP14012 Amg | Experimental | DWP14012 Amg, tablets, orally, repeated dose administration(for 7days) |
|
| Cohort 8: DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, repeated dose administration(for 7days) |
|
| Cohort 9: DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, repeated dose administration(for 7days) |
|
| Cohort 7-10: Placebo | Placebo Comparator | DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 7days) |
|
| Cohort 7-10: Esomeprazole | Active Comparator | Nexium®, orally, repeated dose administration(for 7days) |
|
| Cohort 9: DWP14012 Dmg | Experimental | DWP14012 Dmg, tablets, orally, repeated dose administration(for 7days) |
|
| Placebo | Drug | DWP14012 placebo-matching tablets, Active control placebo-matching tablets |
|
| Esomeprazole | Drug | Nexium® |
|
in multiple ascending dose cohort
| 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| Cmin,ss: Minimum concentration of DWP14012 at steady state | in multiple ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| Tmax: Time of maximum concentration | in single ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| Tmax,ss: Time of maximum concentration at steady state | in multiple ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| AUClast: Area under the plasma concentration-time curve from time 0 to 48hours | in single ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| AUCinf: Area under the plasma concentration-time curve from time 0 to infinity | in single ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval) | in multiple ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| T1/2: Elimination half-life | in single ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| T1/2: Elimination half-life | in multiple ascending dose cohort | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours |
| 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 multiple administration of the investigational products, 24hr gastric pH monitoring started. | Day 7 |
| Serum gastrin concentration profile | Day -2(Randomization) to Day 11~18(Post-study visit) |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |