Clincosm LogoSign in Get a demo

Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04171687
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
5.6
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the influence of tegoprazan or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Evaluation Criteria:

  • Primary outcome Pharmacodynamic assessments using P2Y12 assay

  • Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss , CLss/F of Clopidogrel

  • 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 :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Explore the Drug Interaction of Tegoprazan or RAPA113 and Clopidogrel After Oral Administration in Healthy Male Volunteers
Actual Study Start Date :
Oct 21, 2019
Actual Primary Completion Date :
Feb 7, 2020
Actual Study Completion Date :
Apr 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Clopidogrel 75 mg

Oral administration of clopidogrel 75 mg tablet once daily for 7 days

Drug: Clopidogrel 75mg
Clopidogrel 75 mg tablet
Other Names:
  • Plavix

    		•
    Experimental: Clopidogrel 75 mg + Tegoprazan 50 mg

    Oral administration of clopidogrel 75 mg tablet and Tegoprazan 50mg tablet once daily for 7 days

    Drug: Clopidogrel 75mg
    Clopidogrel 75 mg tablet
    Other Names:
  • Plavix

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

    		•
    Experimental: Clopidogrel 75 mg + RAPA113

    Oral administration of clopidogrel 75 mg tablet and RAPA113 tablet once daily for 7 days

    Drug: Clopidogrel 75mg
    Clopidogrel 75 mg tablet
    Other Names:
  • Plavix

    • Drug: RAPA113
    RAPA113 tablet

    Outcome Measures

    Primary Outcome Measures

    1. Change in P2Y12 Reaction Unit (PRU) from baseline [Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period]

      Pharmacodynamics blood sampling to measure PRU using VerifyNow® system

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy adult males aged ≥ 19 years and ≤ 50 years on the date of the written informed consent

    • Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.5 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

    • Helicobacter pylori negative

    • Voluntarily decided to participate in the study and provided written informed consent before any screening procedure

    Exclusion Criteria:

    • Has a history of or currently has clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood, tumor, cardiovascular system or psychiatric disease

    • Has a history of gastrointestinal diseases (such as Crohn's disease, ulcer, etc.) or surgery (except for simple appendectomy or hernia) that can affect the absorption of drugs

    • Has a genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

    • Has a clinically significant history of hemorrhage (e.g. Gastric ulcers, intracranial bleeding, haemophilia, gastrointestinal bleeding, urinary tract bleeding, vitreous hemorrhage, etc.)

    • P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening

    • Considered ineligible to participate in the study based on screening test(by asking condition, vital sign, 12-lead ECG, physical exam, laboratory test etc.) results :

    1. Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10%

    2. AST (GOT), and ALT (GPT) levels greater than 1.25x of the upper limit of normal range

    3. Blood total bilirubin levels greater than 1.5x of the upper limit of normal range

    4. Hemoglobin levels less than 12.0 g/dL

    5. eGFR (estimated Glomerular Filtration Rate) using MDRD (Modification of Diet in Renal Disaster) < 60 mL/min/1.73 m2

    : eGFR (estimated glomerular filtration rate) (mL/min/1.73m2) = 175 x [serum creatinine (mg/dL)]-1.154 x [age]-0.203

    1. positive as a result of serum examination (B-type hepatitis test, hepatitis C test, human immunodeficiency virus test, syphilis test)

    2. Systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 50 mmHg or > 100 mmHg, or pulse rate < 45 beats/minute or > 100 beats/minute when vital signs are measured in sitting position after resting for at least 5 minutes during screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    • Principal Investigator: Min Soo Park, Severance 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:
    NCT04171687
    Other Study ID Numbers:
    • CJ_APA_113
    First Posted:
    Nov 21, 2019
    Last Update Posted:
    May 8, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Clopidogrel

    Study Results

    No Results Posted as of May 8, 2020