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

NCT ID: NCT04171687

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2020-04-09

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.

Detailed Description

Evaluation Criteria:

• Primary outcome Pharmacodynamic assessments using P2Y12 assay
• Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss , CLss/F of Clopidogrel
• Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopidogrel 75 mg

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

Group Type: ACTIVE_COMPARATOR

Clopidogrel 75mg

Intervention Type: DRUG

Clopidogrel 75 mg tablet

Clopidogrel 75 mg + Tegoprazan 50 mg

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

Group Type: EXPERIMENTAL

Clopidogrel 75mg

Intervention Type: DRUG

Clopidogrel 75 mg tablet

Tegoprazan 50 mg

Intervention Type: DRUG

Tegoprazan 50 mg tablet

Clopidogrel 75 mg + RAPA113

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

Group Type: EXPERIMENTAL

Clopidogrel 75mg

Intervention Type: DRUG

Clopidogrel 75 mg tablet

RAPA113

Intervention Type: DRUG

RAPA113 tablet

Interventions

Clopidogrel 75mg

Clopidogrel 75 mg tablet

Intervention Type: DRUG

Tegoprazan 50 mg

Tegoprazan 50 mg tablet

Intervention Type: DRUG

RAPA113

RAPA113 tablet

Intervention Type: DRUG

Other Intervention Names

Plavix; K-CAB

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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 :

1. Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10%

2. AST (GOT), and ALT (GPT) levels greater than 1.25x of the upper limit of normal range

3. Blood total bilirubin levels greater than 1.5x of the upper limit of normal range

4. Hemoglobin levels less than 12.0 g/dL

5. 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

6. positive as a result of serum examination (B-type hepatitis test, hepatitis C test, human immunodeficiency virus test, syphilis test)

7. 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Soo Park

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Dept of Clinical Pharmacology

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_APA_113

Identifier Type: -

Identifier Source: org_study_id