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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Anti-Ulcer Agents

Treatments: Drug: Cohort 4 (JP-1366 D mg); Drug: Cohort 8 (JP-1366 H mg); Drug: Cohort 3 (JP-1366 C mg); Drug: Cohort 5 (JP-1366 E mg); Drug: Cohort 9 (JP-1366 I mg); Drug: Cohort 2 (JP-1366 B mg); Drug: Cohort 6 (JP-1366 F mg); Drug: Cohort 7 (JP-1366 G mg); Drug: Cohort 1 (JP-1366 A mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03383042

JP-1366-101-FIH

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 9 patient groups

Cohort 1

Experimental group

Description:

Single-ascending cohort 1

Treatment:

Drug: Cohort 1 (JP-1366 A mg)

Cohort 2

Experimental group

Description:

Single-ascending cohort 2

Treatment:

Drug: Cohort 2 (JP-1366 B mg)

Cohort 3

Experimental group

Description:

Single-ascending cohort 3

Treatment:

Drug: Cohort 3 (JP-1366 C mg)

Cohort 4

Experimental group

Description:

Single-ascending cohort 4

Treatment:

Drug: Cohort 4 (JP-1366 D mg)

Cohort 5

Experimental group

Description:

Single-ascending cohort 5

Treatment:

Drug: Cohort 5 (JP-1366 E mg)

Cohort 6

Experimental group

Description:

Multiple-ascending cohort 1

Treatment:

Drug: Cohort 6 (JP-1366 F mg)

Cohort 7

Experimental group

Description:

Multiple-ascending cohort 2

Treatment:

Drug: Cohort 7 (JP-1366 G mg)

Cohort 8

Experimental group

Description:

Multiple-ascending cohort 3

Treatment:

Drug: Cohort 8 (JP-1366 H mg)

Cohort 9

Experimental group

Description:

Multiple-ascending cohort 4

Treatment:

Drug: Cohort 9 (JP-1366 I mg)