Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06164834
• Other study ID #: IN_APA_123
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 5, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: HK inno.N Corporation
• Contact: Eun Ji Kim
• Phone: 82-2-6477-0290
• Email: eunji.kim24[@]inno-n.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Clopidogrel 75 mg
Clopidogrel 75 mg tablet
• Tegoprazan 25 mg
Tegoprazan 25 mg tablet
• Esomeprazole 20mg
Esomeprazole 20 mg tablet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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