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

Sponsor
Jeil Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03383042
Collaborator
(none)
115
Enrollment
1
Location
9
Arms
15.4
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 22, 2017
Actual Primary Completion Date :
Nov 23, 2018
Actual Study Completion Date :
Apr 5, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. t1/2 [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

    6. 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

    7. 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

    8. 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

    9. 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

    10. 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

    11. 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

    12. Percentage of total time that the intragastric pH was above 4 [0-24 hours(Day -1), 0-24 hours(Day 1)]

      SAD

    13. 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

    14. Serum gastrin concentration [Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose]

      SAD

    15. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital(SNUH) Seoul Jongno-Gu Korea, Republic of 110-744

    Sponsors and Collaborators

    • Jeil Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeil Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03383042
    Other Study ID Numbers:
    • JP-1366-101-FIH
    First Posted:
    Dec 26, 2017
    Last Update Posted:
    Apr 22, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 22, 2019