Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants

NCT03814642 | Completed Phase 1

• 1 other identifier: CJ_APA_110
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and clopidogrel in healthy male volunteers.

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, 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 50 mg

EXPERIMENTAL

Oral administration of clopidogrel 75 mg tablet and tegoprazan 50 mg tablet once daily for 7 days

Drug: Clopidogrel 75 mg; Drug: Tegoprazan 50 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 20 mg

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 50 mg

Tegoprazan 50 mg DRUG

Tegoprazan 50 mg tablet

Also known as: K-CAB

Clopidogrel 75 mg + Tegoprazan 50 mg

Esomeprazole 20 mg DRUG

Esomeprazole 20 mg tablet

Also known as: Nexium

Clopidogrel 75 mg + Esomeprazole 20 mg

Eligibility Criteria

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

You may qualify if:

• Healthy adult males 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
• Helicobacter pylori negative
• Voluntarily decided to participate in the study and provided written informed consent before any screening procedure
• Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.

You may not qualify if:

• Has a history of or currently has clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood, cardiovascular system, urinary system, or psychiatric disease or tumor
• Has a history of or currently has gastrointestinal disorder (gastrointestinal ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product
• Has a history of gastrointestinal surgery (except simple appendectomy and hernia surgery)
• Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or a history of clinically significant hypersensitivity
• Positive serological test including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• Blood total bilirubin, AST (GOT), and ALT (GPT) levels greater than 1.5x of the upper limit of normal range at screening
• Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at screening
• P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
• \*17 allele by CYP2C19 genotyping (Ultrarapid metabolizer)
• Systolic blood pressure \< 90 mmHg or \> 140 mmHg, diastolic blood pressure \< 50 mmHg or \> 95 mmHg, or pulse rate \< 45 beats/minute or \> 100 beats/minute when vital signs are measured in sitting position after resting for at least 5 minutes during screening
• QTc \> 450 msec, PR interval \> 200 msec, QRS interval \> 120 msec, and other clinically significant findings on electrocardiogram at screening
• Has a history of or positive urine screening for drug abuse
• Administration of any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or administration of any over-the-counter (OTC) drug, health functional food or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator)
• Participation in other clinical study or bioequivalence study to receive an investigational product within 3 months prior to the expected date of the first dose
• Donation of whole blood within 2 months or apheresis/receipt of blood transfusion within 1 month prior to the expected date of the first dose

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

• In-Jin Jang

  Seoul National University Hospital, Dept. of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

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: January 20, 2019
• First Posted: January 24, 2019
• Study Start: January 21, 2019
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

KR (1)