Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

NCT06164834 | Unknown Phase 1

• 1 other identifier: IN_APA_123
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Clopidogrel 75 mg

ACTIVE COMPARATOR

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

Drug: Clopidogrel 75 mg

Clopidogrel 75 mg + Tegoprazan 25 mg

EXPERIMENTAL

Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days

Drug: Clopidogrel 75 mg; Drug: Tegoprazan 25 mg

Clopidogrel 75 mg + Esomeprazole 20 mg

EXPERIMENTAL

Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days

Drug: Clopidogrel 75 mg; Drug: Esomeprazole 20mg

Interventions

Clopidogrel 75 mg DRUG

Clopidogrel 75 mg tablet

Also known as: Plavix

Clopidogrel 75 mg; Clopidogrel 75 mg + Esomeprazole 20 mg; Clopidogrel 75 mg + Tegoprazan 25 mg

Tegoprazan 25 mg DRUG

Tegoprazan 25 mg tablet

Also known as: K-CAB

Clopidogrel 75 mg + Tegoprazan 25 mg

Esomeprazole 20mg DRUG

Esomeprazole 20 mg tablet

Also known as: Nexium

Clopidogrel 75 mg + Esomeprazole 20 mg

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital, Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Clopidogrel; tegoprazan; Esomeprazole

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Benzimidazoles

Study Officials

• Seung Hwan Lee

  Seoul National University Hospital, Dept. of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Ji Kim

CONTACT

82-2-6477-0290; eunji.kim24@inno-n.com

Hee Hyun Kim

CONTACT

82-2-6477-0258; heehyun.kim@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 5, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

KR (1)