Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects

Study Overview
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Brief Summary
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Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects

Official Title
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A Randomized, Open-label, Placebo- and Active- Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects

Conditions
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Anti-Ulcer Agents

Intervention / Treatment
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* Drug: Cohort 1 (JP-1366 A mg)
* Drug: Cohort 2 (JP-1366 B mg)
* Drug: Cohort 3 (JP-1366 C mg)
* Drug: Cohort 4 (JP-1366 D mg)
* Drug: Cohort 5 (JP-1366 E mg)
* Drug: Cohort 6 (JP-1366 F mg)
* Drug: Cohort 7 (JP-1366 G mg)
* Drug: Cohort 8 (JP-1366 H mg)
* Drug: Cohort 9 (JP-1366 I mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males aged between 19 and 50 at screening 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: Subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history Subject has 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) Subject has been Helicobacter pylori positive AST (SGOT) and ALT (SGPT) > 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization Subject has 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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Male

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single-ascending cohort 1 | Drug: Cohort 1 (JP-1366 A mg)<br>* Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: SAD;|
| Experimental: Cohort 2<br>Single-ascending cohort 2 | Drug: Cohort 2 (JP-1366 B mg)<br>* Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: SAD;|
| Experimental: Cohort 3<br>Single-ascending cohort 3 | Drug: Cohort 3 (JP-1366 C mg)<br>* Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: SAD;|
| Experimental: Cohort 4<br>Single-ascending cohort 4 | Drug: Cohort 4 (JP-1366 D mg)<br>* Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: SAD;|
| Experimental: Cohort 5<br>Single-ascending cohort 5 | Drug: Cohort 5 (JP-1366 E mg)<br>* Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: SAD;|
| Experimental: Cohort 6<br>Multiple-ascending cohort 1 | Drug: Cohort 6 (JP-1366 F mg)<br>* Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: MAD;|
| Experimental: Cohort 7<br>Multiple-ascending cohort 2 | Drug: Cohort 7 (JP-1366 G mg)<br>* Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: MAD;|
| Experimental: Cohort 8<br>Multiple-ascending cohort 3 | Drug: Cohort 8 (JP-1366 H mg)<br>* Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: MAD;|
| Experimental: Cohort 9<br>Multiple-ascending cohort 4 | Drug: Cohort 9 (JP-1366 I mg)<br>* Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg<br>* Other names: MAD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose | 
| AUClast | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose | 
| AUCinf | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose | 
| tmax | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose | 
| t1/2 | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose | 
| Cmax,ss | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose | 
| Cmin,ss | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose | 
| Cav,ss | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose | 
| AUCτ | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose | 
| tmax,ss | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose | 
| t1/2 | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose | 
| Percentage of total time that the intragastric pH was above 4 | SAD | 0-24 hours(Day -1), 0-24 hours(Day 1) | 
| Percentage of total time that the intragastric pH was above 4 | MAD | 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7) | 
| Serum gastrin concentration | SAD | Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose | 
| Serum gastrin concentration | MAD | Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24h post-dose, Day 4 pre-dose, Day 6 pre-dose, Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose |