Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Anti-Ulcer Agents
- Interventions
- Drug: Cohort 5 (JP-1366 E mg)Drug: Cohort 9 (JP-1366 I mg)Drug: Cohort 2 (JP-1366 B mg)Drug: Cohort 4 (JP-1366 D mg)Drug: Cohort 6 (JP-1366 F mg)Drug: Cohort 8 (JP-1366 H mg)Drug: Cohort 1 (JP-1366 A mg)Drug: Cohort 3 (JP-1366 C mg)Drug: Cohort 7 (JP-1366 G mg)
- Registration Number
- NCT03383042
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Brief Summary
Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 115
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 5 Cohort 5 (JP-1366 E mg) Single-ascending cohort 5 Cohort 9 Cohort 9 (JP-1366 I mg) Multiple-ascending cohort 4 Cohort 2 Cohort 2 (JP-1366 B mg) Single-ascending cohort 2 Cohort 4 Cohort 4 (JP-1366 D mg) Single-ascending cohort 4 Cohort 6 Cohort 6 (JP-1366 F mg) Multiple-ascending cohort 1 Cohort 8 Cohort 8 (JP-1366 H mg) Multiple-ascending cohort 3 Cohort 1 Cohort 1 (JP-1366 A mg) Single-ascending cohort 1 Cohort 3 Cohort 3 (JP-1366 C mg) Single-ascending cohort 3 Cohort 7 Cohort 7 (JP-1366 G mg) Multiple-ascending cohort 2
- Primary Outcome Measures
Name Time Method Cmax 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 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 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 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 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
Cmax,ss 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 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 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
AUCĪ 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 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 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7) MAD
Serum gastrin concentration 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital(SNUH)
đ°đˇSeoul, Jongno-Gu, Korea, Republic of