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Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants

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ClinicalTrials.gov Identifier: NCT03814642
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief Summary:
This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and clopidogrel in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Clopidogrel 75 mg Drug: Tegoprazan 50 mg Drug: Esomeprazole 20 mg Phase 1

Detailed Description:

Evaluation Criteria:

  • Pharmacodynamic assessments using P2Y12 assay
  • Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel According to CYP2C19 Genotypes in Healthy Male Volunteers
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clopidogrel 75 mg
Oral administration of clopidogrel 75 mg tablet once daily for 7 days
Drug: Clopidogrel 75 mg
Clopidogrel 75 mg tablet
Other Name: Plavix

Experimental: Clopidogrel 75 mg + Tegoprazan 50 mg
Oral administration of clopidogrel 75 mg tablet and tegoprazan 50 mg tablet once daily for 7 days
Drug: Clopidogrel 75 mg
Clopidogrel 75 mg tablet
Other Name: Plavix

Drug: Tegoprazan 50 mg
Tegoprazan 50 mg tablet
Other Name: K-CAB

Experimental: Clopidogrel 75 mg + Esomeprazole 20 mg
Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days
Drug: Clopidogrel 75 mg
Clopidogrel 75 mg tablet
Other Name: Plavix

Drug: Esomeprazole 20 mg
Esomeprazole 20 mg tablet
Other Name: Nexium




Primary Outcome Measures :
  1. Change in P2Y12 Reaction Unit (PRU) from baseline [ Time Frame: Pre-dose(0h) on days 1, 3, 5, and 8 in each period ]
    Pharmacodynamic blood sampling to measure PRU using VerifyNow® system



Information from the National Library of Medicine

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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 ≥ 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 ≥ 18.0 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
  • Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.

Exclusion Criteria:

  • Has a history of or currently has clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood, cardiovascular system, urinary system, or psychiatric disease or tumor
  • Has a history of or currently has gastrointestinal disorder (gastrointestinal ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product
  • Has a history of gastrointestinal surgery (except simple appendectomy and hernia surgery)
  • Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or a history of clinically significant hypersensitivity
  • Positive serological test including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  • Blood total bilirubin, AST (GOT), and ALT (GPT) levels greater than 1.5x of the upper limit of normal range at screening
  • Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at screening
  • P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
  • *17 allele by CYP2C19 genotyping (Ultrarapid metabolizer)
  • Systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 95 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
  • QTc > 450 msec, PR interval > 200 msec, QRS interval > 120 msec, and other clinically significant findings on electrocardiogram at screening
  • Has a history of or positive urine screening for drug abuse
  • Administration of any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or administration of any over-the-counter (OTC) drug, health functional food or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator)
  • Participation in other clinical study or bioequivalence study to receive an investigational product within 3 months prior to the expected date of the first dose
  • Donation of whole blood within 2 months or apheresis/receipt of blood transfusion within 1 month prior to the expected date of the first dose
  • Excessive caffeine intake (> 5 units/day) or persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking during hospitalization period
  • Smoking for more than 3 months prior to the study or inability to cease smoking throughout the study
  • Inability to refrain from grapefruit-containing food from 24 hours before admission to discharge
  • Inability to refrain from caffeine-containing food (coffee, tea (black tea, green tea, etc.), carbonated drink, coffee-flavored milk, nutritional tonic, etc.) from 24 hours before admission to discharge
  • Inability to use a medically acceptable method of contraception throughout the study. Medically acceptable methods of contraception include use of intrauterine device with established failure rate of contraception by spouse (or partner), concomitant use of barrier method (for male or for female) and spermicide, or surgical procedure on subject himself or his partner (vasectomy, tubal resection/ligation, hysterectomy)
  • Considered ineligible to participate in the study by the investigator based on laboratory test results or other reasons

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): NCT03814642


Contacts
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Contact: Sun Young Wang +82-2-6477-0286 sy.wang@kolmar.co.kr
Contact: Ji Yeon Nam +82-2-6477-0277 jy.nam@kolmar.co.kr

Locations
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Korea, Republic of
Seoul National University Hospital, Clinical Trial Center Recruiting
Seoul, Korea, Republic of
Contact: In-Jin Jang, MD, PhD    +82-2-2072-1666    ijjang@snu.ac.kr   
Principal Investigator: In-Jin Jang, MD, PhD         
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: In-Jin Jang Seoul National University Hospital, Dept. of Clinical Pharmacology

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03814642     History of Changes
Other Study ID Numbers: CJ_APA_110
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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Clopidogrel
Esomeprazole
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors