Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel

Overview

This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows; 1. Primary – To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel – To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel 2. Secondary – To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel – To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel – To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel

Full Title of Study: “Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions on the Pharmacokinetics/Pharmacodynamics of Clopidogrel in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

Interventions

  • Drug: Clopidogrel+Aspirin
    • Clopidogrel 75 mg, Aspirin 100 mg

Arms, Groups and Cohorts

  • Experimental: Clopidogrel+Aspirin
    • Clopidogrel on Day 1, Aspirin on Day 2 – Day 14, Clopidogrel + Aspirin Day 15, Aspirin on Day 16 – Day 28, Clopidogrel + Aspirin Day 29

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics of Clopidogrel
    • Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h postdose on Day 1, Day 15 and Day 29
    • Plasma concentration of clopidogrel and active metabolite of clopidogrel
  • Pharmacodynamics of clopidogrel
    • Time Frame: Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29
    • Relative inhibition of platelet aggregation by aggregometer or VerifyNow

Secondary Measures

  • mRNA/microRNA/endogenous metabolite
    • Time Frame: predose on Day 1, Day 8, Day 15, Day 22 and Day 29
    • mRNA of PON1 and CYP2C19, CYP3A5, MDR1 microRNA endogenous metabolite

Participating in This Clinical Trial

Inclusion Criteria

  • 1. Healthy male subjects aged 20 – 45 years. – 2. A body weight in the range of 50 kg (inclusive) – 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) – 27 kg/m2 (inclusive). – 3. Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures. Exclusion Criteria:

  • 1. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel or aspirin) – 2. Clinically relevant abnormal medical history that could interfere with the objectives of the study. – 3. A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug. – 4. A subject whose lab test results are as follows; Platelet count or PT, aPTT < 0.9 x lower limit of reference range of > 1.1 x upper limit of reference range. – 5. A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg. – 6. Presence or history of drug abuse or positive result in urine drug screening test. – 7. Participation in other clinical trial within 2 months before first dose. – 8. Use of CYP inducer (ex. rifampin) within 4 weeks before first dose. – 9. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose. – 10.Use of grapefruit juice within 1 week before first dose. – 11. Blood donation during 2 months or apheresis during 1 month before the study. – 12. Use of alcohol over 21 units/weeks – 13. Smoking of more than 10 cigarettes/days within 3 months before first dose. – 14. Subject judged not eligible for study participation by investigator.

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: In-Jin Jang, MD, PhD, Professor – Seoul National University Hospital
  • Overall Official(s)
    • In-Jin Jang, MD, Principal Investigator, Seoul National University Hospital

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