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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03383042

Enrollment

115

Registered

2017-12-26

Start date

2017-12-22

Completion date

2019-04-05

Last updated

2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Ulcer Agents

Brief summary

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

Interventions

DRUGCohort 1 (JP-1366 A mg)

Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 2 (JP-1366 B mg)

Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 3 (JP-1366 C mg)

Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 4 (JP-1366 D mg)

Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 5 (JP-1366 E mg)

Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 6 (JP-1366 F mg)

Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 7 (JP-1366 G mg)

Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 8 (JP-1366 H mg)

Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg

DRUGCohort 9 (JP-1366 I mg)

Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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 * 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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026