Completed

NCT Number: NCT03383042

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

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

Completed

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Key information

Conditions

Anti-Ulcer Agents

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital(SNUH)

Seoul, Jongno-Gu, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort 1 (JP-1366 A mg)

Drug

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

Other names: SAD

Cohort 2 (JP-1366 B mg)

Drug

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

Other names: SAD

Cohort 3 (JP-1366 C mg)

Drug

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

Other names: SAD

Cohort 4 (JP-1366 D mg)

Drug

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

Other names: SAD

Cohort 5 (JP-1366 E mg)

Drug

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

Other names: SAD

Cohort 6 (JP-1366 F mg)

Drug

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

Other names: MAD

Cohort 7 (JP-1366 G mg)

Drug

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

Other names: MAD

Cohort 8 (JP-1366 H mg)

Drug

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

Other names: MAD

Cohort 9 (JP-1366 I mg)

Drug

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

Other names: MAD

Primary outcomes

Cmax

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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
t1/2

Time frame: 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

Time frame: 0-24 hours(Day -1), 0-24 hours(Day 1)

SAD
Percentage of total time that the intragastric pH was above 4

Time frame: 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7)

MAD
Serum gastrin concentration

Time frame: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose

SAD
Serum gastrin concentration

Time frame: 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

MAD

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Dec 26, 2017
Registry last updated: Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Seoul National University Hospital(SNUH)

Who can participate

Treatment and study plan

Cohort 1 (JP-1366 A mg)

Cohort 2 (JP-1366 B mg)

Cohort 3 (JP-1366 C mg)

Cohort 4 (JP-1366 D mg)

Cohort 5 (JP-1366 E mg)

Cohort 6 (JP-1366 F mg)

Cohort 7 (JP-1366 G mg)

Cohort 8 (JP-1366 H mg)

Cohort 9 (JP-1366 I mg)

Primary outcomes

Cmax

AUClast

AUCinf

tmax

t1/2

Cmax,ss

Cmin,ss

Cav,ss

AUCτ

tmax,ss

t1/2

Percentage of total time that the intragastric pH was above 4

Percentage of total time that the intragastric pH was above 4

Serum gastrin concentration

Serum gastrin concentration

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian