Healthy
Conditions
Brief summary
This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects
Interventions
DRUGDWP14012 Amg
DWP14012 Amg
DRUGDWP14012 Bmg
DWP14012 Bmg
DRUGClarithromycin
Clarithromycin 500 mg
DRUGAmoxicillin
Amoxicillin 1 g
DRUGLansoprazole
Lansoprazole 30 mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
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 * Part I: Those who have been helicobacter pylori negative at screening Part II: Those who have been helicobacter pylori positive at screening * 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 whose plasma AST (SGOT) and ALT (SGPT) exceed to the upper limit of the normal range * Those who have anatomical disability in insertion and maintenance of pH meter catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | Part I: each period (Group A, B, C, D) Part II: Group A, B |
| Cmin,ss: Minimum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | Part I: each period (Group A, B, C, D) Part II: Group A, B |
| Cav,ss: Average concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | Part I: each period (Group A, B, C, D) Part II: Group A, B |
| AUCt,ss: Area under the drug concentration-time curve within a dosing interval at steady states | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | Part I: each period (Group A, B, C, D) Part II: Group A, B |
| Tmax,ss: Time of maximum concentration at steady state | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | Part I: each period (Group A, B, C, D) Part II: Group A, B |
| T1/2: Elimination half-life | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | Part I: each period (Group A, B, C, D) Part II: Group A, B |
| Percentage of total time that the intragastric pH was above 4 | Period 1 Day -1 and Group A, C Day 7 0~24 hours | Part I |
| Percentage of total time that the intragastric pH was above 6 | Period 1 day -1 and Group A, C Day 7 0~24 hours | Part I |
| Serum gastrin concentration profile | Period 1 Day -1 and Group A, C Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours | Part I |
| Number of participants with Adverse Events (AE) | Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II) | All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe |
| Number of Participants With Clinically Significant Vital Sign findings | Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II) | Blood pressure(mmHg), pulse (beats/min) 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 54~60 (Post-study visit of Part I) and Day 36~42 (Follow up visit of Part II) | Ventricular rate(beats/min), RR, PR interval(msec), QRS duration(msec), 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 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II) | Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability. |
Countries
South Korea
Outcome results
None listed