Healthy
Conditions
Brief summary
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.
Interventions
DRUGDWP14012
DWP14012 tablets
DRUGPlacebo
DWP14012 placebo-matching tablets, Active control placebo-matching tablets
DRUGEsomeprazole
Nexium®
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males aged between 19 and 50 at screening * Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 27.0 * Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of Participants With Adverse Events (AE) | Day -2(Randomization) to Day 11~18(Post-study visit) | All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate adn severe. |
| Number and percentage of Participants With Adverse Drug Reactions (ADR) | Day -2(Randomization) to Day 11~18(Post-study visit) | An adverse drug reaction (ADR) is an injury caused by taking an investigational product. |
| Number of Participants With Clinically Significant Vital Sign findings | Day -2(Randomization) to Day 11~18(Post-study visit) | Blood pressure, pulse and body temperature were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability. |
| Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings | Day -2(Randomization) to Day 11~18(Post-study visit) | 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). |
| Number of Participants With Clinically Significant Laboratory results | Day -2(Randomization) to Day 11~18(Post-study visit) | Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast: Area under the plasma concentration-time curve from time 0 to 48hours | 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 | in single ascending dose cohort |
| AUCinf: Area under the plasma concentration-time curve from time 0 to infinity | 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 | in single ascending dose cohort |
| AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval) | 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 | in multiple ascending dose cohort |
| Cmax: Maximum concentration of DWP14012 | 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 | in single ascending dose cohort |
| 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. |
| Serum gastrin concentration profile | Day -2(Randomization) to Day 11~18(Post-study visit) | — |
| T1/2: Elimination half-life | 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 | in single ascending dose cohort |
| Cmax,ss: Maximum concentration of DWP14012 at steady state | 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 | in multiple ascending dose cohort |
| Cmin,ss: Minimum concentration of DWP14012 at steady state | 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 | in multiple ascending dose cohort |
| Tmax: Time of maximum concentration | 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 | in single ascending dose cohort |
| Tmax,ss: Time of maximum concentration at steady state | 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 | in multiple ascending dose cohort |
Countries
South Korea
Outcome results
None listed