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

Anti-Ulcer Agents Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383042
• Other study ID #: JP-1366-101-FIH
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: April 2019
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 5, 2019
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anti-Ulcer Agents

Intervention

Drug:
• Cohort 1 (JP-1366 A mg)
Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 2 (JP-1366 B mg)
Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 3 (JP-1366 C mg)
Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 4 (JP-1366 D mg)
Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 5 (JP-1366 E mg)
Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 6 (JP-1366 F mg)
Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 7 (JP-1366 G mg)
Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 8 (JP-1366 H mg)
Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg
• Cohort 9 (JP-1366 I mg)
Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital(SNUH)	Seoul	Jongno-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	AUCt	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
Primary	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
Primary	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
Primary	Percentage of total time that the intragastric pH was above 4	SAD	0-24 hours(Day -1), 0-24 hours(Day 1)
Primary	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)
Primary	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
Primary	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