Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers

NCT04171687 | Completed Phase 1

• 1 other identifier: CJ_APA_113
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the influence of tegoprazan or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in P2Y12 Reaction Unit (PRU) from baseline

  Pharmacodynamics 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 75mg

Clopidogrel 75 mg + Tegoprazan 50 mg

EXPERIMENTAL

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

Drug: Clopidogrel 75mg; Drug: Tegoprazan 50 mg

Clopidogrel 75 mg + RAPA113

EXPERIMENTAL

Oral administration of clopidogrel 75 mg tablet and RAPA113 tablet once daily for 7 days

Drug: Clopidogrel 75mg; Drug: RAPA113

Interventions

Clopidogrel 75mg DRUG

Clopidogrel 75 mg tablet

Also known as: Plavix

Clopidogrel 75 mg; Clopidogrel 75 mg + RAPA113; 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

RAPA113 DRUG

RAPA113 tablet

Clopidogrel 75 mg + RAPA113

Eligibility Criteria

• Age: 19 Years - 55 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 ≥ 18.5 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

You may not qualify if:

• Has a history of or currently has clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood, tumor, cardiovascular system or psychiatric disease
• Has a history of gastrointestinal diseases (such as Crohn's disease, ulcer, etc.) or surgery (except for simple appendectomy or hernia) that can affect the absorption of drugs
• Has a genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Has a clinically significant history of hemorrhage (e.g. Gastric ulcers, intracranial bleeding, haemophilia, gastrointestinal bleeding, urinary tract bleeding, vitreous hemorrhage, etc.)
• P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
• Considered ineligible to participate in the study based on screening test(by asking condition, vital sign, 12-lead ECG, physical exam, laboratory test etc.) results :
• Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10%
• AST (GOT), and ALT (GPT) levels greater than 1.25x of the upper limit of normal range
• Blood total bilirubin levels greater than 1.5x of the upper limit of normal range
• Hemoglobin levels less than 12.0 g/dL
• eGFR (estimated Glomerular Filtration Rate) using MDRD (Modification of Diet in Renal Disaster) \< 60 mL/min/1.73 m2
• : eGFR (estimated glomerular filtration rate) (mL/min/1.73m2) = 175 x \[serum creatinine (mg/dL)\]-1.154 x \[age\]-0.203
• positive as a result of serum examination (B-type hepatitis test, hepatitis C test, human immunodeficiency virus test, syphilis test)
• Systolic blood pressure \< 90 mmHg or \> 150 mmHg, diastolic blood pressure \< 50 mmHg or \> 100 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Clopidogrel; tegoprazan

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

Study Officials

• Min Soo Park

  Severance 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: November 19, 2019
• First Posted: November 21, 2019
• Study Start: October 21, 2019
• Primary Completion: February 7, 2020
• Study Completion: April 9, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

KR (1)