Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel in Healthy Subjects

This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Clopidogrel 75 mg; Drug: Tegoprazan 25 mg; Drug: Esomeprazole 20mg

Detailed Description

Evaluation Criteria:

• Primary outcome Pharmacodynamic assessments using P2Y12 assay
• Secondary outcome Pharmacokinetics assessments on Cmax,ss, Cmin,ss, Cavg,ss, AUCτ,ss, Tmax,ss, t1/2,ss, CLss/F, Vd,ss/F, and PTF of clopidogrel
• Safety assessments with adverse event monitoring including subjective/ objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Eun Ji Kim; Phone Number: 82-2-6477-0290; Email: eunji.kim24@inno-n.com
• Study Contact Backup: Name: Hee Hyun Kim; Phone Number: 82-2-6477-0258; Email: heehyun.kim@inno-n.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital, Clinical Trial Center
    • Contact: Seung Hwan Lee, MD, PhD; Phone Number: 82-2-2072-2343; Email: leejh413@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults 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
• Is given a detailed explanation and fully understood the study, then voluntarily decided to participate and provided written informed consent before any screening procedure
• Negative for serum Helicobacter pylori antibodies
• Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.

Exclusion Criteria:

• Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
• Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
• Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
• Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
• Blood total bilirubin, AST (GOT), and ALT (GPT) > 1.5 x upper limit of normal range at the screening test
• Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at the screening test
• Systolic blood pressure is < 90 mmHg or > 139 mmHg, diastolic blood pressure < 50 mmHg or > 89 mmHg, or pulse rate is < 45 beats/minute or > 100 beats/minute when vital signs are measured in sitting position after resting for at least 3 minutes at the screening test
• Showing the following findings on ECG at the screening test: QTc > 450 msec, PR interval > 210 msec, QRS interval > 120 msec, Other clinically significant findings
• P2Y12 Reaction Unit (PRU) outside the upper/lower limit of normal range by 10% as a result of P2Y12 assay at the screening test
• History of drug abuse or positive urine screening for drug abuse
• Considered ineligible to participate in the study by the investigator based on laboratory test results or other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Plavix
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 Names: Plavix; Drug: Esomeprazole 20mg; Esomeprazole 20 mg tablet; Other Names: Nexium
Experimental: Clopidogrel 75 mg + Tegoprazan 25 mg; Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days	Drug: Clopidogrel 75 mg; Clopidogrel 75 mg tablet; Other Names: Plavix; Drug: Tegoprazan 25 mg; Tegoprazan 25 mg tablet; Other Names: K-CAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in P2Y12 Reaction Unit (PRU) from baseline	Pharmacodynamic blood sampling to measure PRU using VerifyNow® system	Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Seung Hwan Lee, Seoul National University Hospital, Dept. of Clinical Pharmacology

Study record dates

Study Major Dates

• Study Start (Estimated): December 5, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Clopidogrel; Esomeprazole
• Other Study ID Numbers: IN_APA_123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No