NCT03383042

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

December 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

December 18, 2017

Last Update Submit

April 18, 2019

Conditions

Anti-Ulcer Agents

Outcome Measures

Primary Outcomes (15)

  • 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

Study Arms (9)

Cohort 1

EXPERIMENTAL

Single-ascending cohort 1

Drug: Cohort 1 (JP-1366 A mg)

Cohort 2

EXPERIMENTAL

Single-ascending cohort 2

Drug: Cohort 2 (JP-1366 B mg)

Cohort 3

EXPERIMENTAL

Single-ascending cohort 3

Drug: Cohort 3 (JP-1366 C mg)

Cohort 4

EXPERIMENTAL

Single-ascending cohort 4

Drug: Cohort 4 (JP-1366 D mg)

Cohort 5

EXPERIMENTAL

Single-ascending cohort 5

Drug: Cohort 5 (JP-1366 E mg)

Cohort 6

EXPERIMENTAL

Multiple-ascending cohort 1

Drug: Cohort 6 (JP-1366 F mg)

Cohort 7

EXPERIMENTAL

Multiple-ascending cohort 2

Drug: Cohort 7 (JP-1366 G mg)

Cohort 8

EXPERIMENTAL

Multiple-ascending cohort 3

Drug: Cohort 8 (JP-1366 H mg)

Cohort 9

EXPERIMENTAL

Multiple-ascending cohort 4

Drug: Cohort 9 (JP-1366 I mg)

Interventions

Cohort 1 (JP-1366 A mg)DRUG

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

Also known as: SAD
Cohort 1
Cohort 2 (JP-1366 B mg)DRUG

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

Also known as: SAD
Cohort 2
Cohort 3 (JP-1366 C mg)DRUG

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

Also known as: SAD
Cohort 3
Cohort 4 (JP-1366 D mg)DRUG

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

Also known as: SAD
Cohort 4
Cohort 5 (JP-1366 E mg)DRUG

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

Also known as: SAD
Cohort 5
Cohort 6 (JP-1366 F mg)DRUG

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

Also known as: MAD
Cohort 6
Cohort 7 (JP-1366 G mg)DRUG

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

Also known as: MAD
Cohort 7
Cohort 8 (JP-1366 H mg)DRUG

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

Also known as: MAD
Cohort 8
Cohort 9 (JP-1366 I mg)DRUG

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

Also known as: MAD
Cohort 9

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital(SNUH)

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

Location

MeSH Terms

Interventions

mycophenolic adenine dinucleotide

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 26, 2017

Study Start

December 22, 2017

Primary Completion

November 23, 2018

Study Completion

April 5, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)