Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04231136
Collaborator
(none)
19
1
3
6.6
2.9

Study Details

Study Description

Brief Summary

This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Evaluation Criteria

  • Pharmacodynamic assessments with intragastric pH

  • Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers
Actual Study Start Date :
Jan 14, 2020
Actual Primary Completion Date :
Jul 29, 2020
Actual Study Completion Date :
Aug 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tegoprazan 50 mg

Oral administration of Tegoprazan 50 mg tablet once a day

Drug: Tegoprazan 50 mg
Tegoprazan 50 mg tablet
Other Names:
  • K-CAB
  • Active Comparator: EAPA115

    Oral administration of EAPA115 once a day

    Drug: EAPA115
    EAPA115

    Active Comparator: RAPA115

    Oral administration of RAPA115 once a day

    Drug: RAPA115
    RAPA115

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]

      The ratio of duration(Duration %) with pH ≥ 4 over 24 hours

    2. Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]

      The ratio of duration(Duration %) with pH ≥ 6 over 24 hours

    3. Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]

      Median pH

    4. Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]

      Mean pH

    5. Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]

      Baseline pH and changes in pH after the administration of investigational products (change of duration %, change of mean pH, change of median pH)

    6. Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period]

      The ratio of duration(Duration %) with pH ≥ 4 during nocturnal period* (*12 hours after administration of investigational product)

    7. Pharmacodynamic Evaluation [Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period]

      The ratio of duration(Duration %) with pH ≥ 6 during nocturnal period* (*12 hours after administration of investigational product)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy adults aged 19 to 65 years (not inclusive) at the time of signing the informed consent form (ICF).

    • Body mass index (BMI) ≥ 17.5 and < 30.5 kg/m2 with a body weight ≥ 45 kg at screening. Body mass index (kg/m2) = weight (kg)/height (m)^2

    • Confirmed as H. pylori negative

    • A subject without any congenital or chronic disease within 3 years, and has no medical examination result as pathological symptoms or signs.

    • A subject determined eligible for this study based on the screening test such as clinical laboratory tests (hematology test, chemistry test, urine test, virus/bacteria test, etc.), vital signs, and electrocardiogram.

    • A subject who is fully informed of the purpose and content of the study and agrees to participate in the study on its own will and signs the consent form approved by the Institutional Review Board (IRB) of the Seoul National University Hospital, prior to participate in the study.

    • A subject who has the ability and willingness to participate throughout the whole study period.

    Exclusion Criteria:
    • A subject with clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychical, neurologic, or immunologic diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or evidence.

    • A subject with a history of gastrointestinal disorders (esophageal diseases such as esophageal achalasia or esophageal stricture, Crohn's disease) or surgery (except for simple appendectomy, herniotomy, and tooth extraction surgery) that may affect the absorption of drugs.

    • A subject with the *17 allele of CYP2C19 (Ultrarapid metabolizer).

    • A subject with AST and ALT levels exceeding 3 times of the upper limit of the reference range in the screening test.

    • A subject with a history of excessive caffeine (> 5 units/day) or regular alcohol consumption exceeding 210 g/week within 6 months of screening test. (1 glass of beer (5%) (250 mL) = 10 g, 1 shot of soju (20%) (50 mL) = 8 g, 1 glass of wine (12%) (125 mL) = 12 g)

    • A subject who participated in other clinical trial or bioequivalence study and administered the study medication within 6 months prior to the first administration of the investigational product of this study.

    • A subject with significant alcohol or drug abuse within a year of screening test.

    • A subject who administered drugs that significantly induce or inhibit drug metabolizing enzymes within 30 days prior to the first administration of the investigational product of this study.

    • A subject who smoked cigarettes more than 20 per day within 6 months of screening test.

    • A subject who administered prescribed drug or over-the-counter drug within 10 days prior to the first administration of the investigational product of this study.

    • A subject who has donated whole blood within 2 months or those who donated the component blood within 1 month prior to the first administration of the investigational product of this study.

    • A subject who has hypersensitivity to the investigational product of this study, benzimidazoles, penicillin and macrolide and its related medical history.

    • A subject with rare genetic problems such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

    • Pregnant or nursing women

    • A subject who cannot use reliable contraception during the entire period of the clinical trial (e.g, condom use, intrauterine device, tubal ligation, cervical cap, contraceptive diaphragm, etc.).

    • A subject who is judged by the investigator to be ineligible to participate in the test.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital, Clinical Trial Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    • Principal Investigator: In-Jin Jang, MD, PhD, Seoul National University Hospital, Dept. of Clinical Pharmacology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT04231136
    Other Study ID Numbers:
    • CJ_APA_115
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Dec 1, 2020
    Last Verified:
    Jan 1, 2020
    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 Dec 1, 2020