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

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

Study Overview

• Status: Completed
• Conditions: Anti-Ulcer Agents
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-Gu
    • Seoul, Jongno-Gu, Korea, Republic of, 110-744
      • Seoul National University Hospital(SNUH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: JP-1366-101-FIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No