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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383042
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jeil Pharmaceutical Co., Ltd.

Study Description
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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
Anti-Ulcer Agents 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
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Study Type : Interventional  (Clinical Trial)
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 : December 22, 2017
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : April 5, 2019
Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: MAD


Outcome Measures
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Primary Outcome Measures :
  1. Cmax [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. AUCτ [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0-24 hours(Day -1), 0-24 hours(Day 1) ]
    SAD

  13. Percentage of total time that the intragastric pH was above 4 [ Time Frame: 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7) ]
    MAD

  14. Serum gastrin concentration [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383042


Locations
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Korea, Republic of
Seoul National University Hospital(SNUH)
Seoul, Jongno-Gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03383042    
Other Study ID Numbers: JP-1366-101-FIH
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No