NCT06164834
Not yet recruiting
Phase 1
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
ConditionsHealthy
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- HK inno.N Corporation
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in P2Y12 Reaction Unit (PRU) from baseline
Overview
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Clopidogrel 75 mg
Active Comparator
Oral administration of clopidogrel 75 mg tablet once daily for 7 days
Intervention: Clopidogrel 75 mg (Drug)
Clopidogrel 75 mg + Tegoprazan 25 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days
Intervention: Clopidogrel 75 mg (Drug)
Clopidogrel 75 mg + Tegoprazan 25 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days
Intervention: Tegoprazan 25 mg (Drug)
Clopidogrel 75 mg + Esomeprazole 20 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days
Intervention: Clopidogrel 75 mg (Drug)
Clopidogrel 75 mg + Esomeprazole 20 mg
Experimental
Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days
Intervention: Esomeprazole 20mg (Drug)
Outcomes
Primary Outcomes
Change in P2Y12 Reaction Unit (PRU) from baseline
Time Frame: Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period
Pharmacodynamic blood sampling to measure PRU using VerifyNow® system
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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