Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

HK inno.N

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Clopidogrel 75 mg; Drug: Tegoprazan 25 mg; Drug: Esomeprazole 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06164834

IN_APA_123

Details and patient eligibility

About

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

Full 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

Enrollment: 48 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Clopidogrel 75 mg

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel 75 mg

Clopidogrel 75 mg + Tegoprazan 25 mg

Experimental group

Description:

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

Treatment:

Drug: Tegoprazan 25 mg

Drug: Clopidogrel 75 mg

Clopidogrel 75 mg + Esomeprazole 20 mg

Experimental group

Description:

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

Treatment:

Drug: Esomeprazole 20mg

Drug: Clopidogrel 75 mg