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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
In-Jin Jang, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01503658
First received: January 1, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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

Condition Intervention Phase
Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
Influence of Aspirin on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
Drug: Clopidogrel+Aspirin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Relative inhibition of platelet aggregation by aggregometer or VerifyNow


Secondary Outcome Measures:
  • mRNA/microRNA/endogenous metabolite [ Time Frame: predose on Day 1, Day 8, Day 15, Day 22 and Day 29 ] [ Designated as safety issue: No ]
    mRNA of PON1 and CYP2C19, CYP3A5, MDR1 microRNA endogenous metabolite


Enrollment: 18
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Clopidogrel+Aspirin
Clopidogrel 75 mg, Aspirin 100 mg

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503658

Locations
Korea, Republic of
Seoul National University Hospital Clinical Trials Center
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: In-Jin Jang, MD Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: In-Jin Jang, MD, PhD, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01503658     History of Changes
Other Study ID Numbers: PGX_Clopidogrel_001
Study First Received: January 1, 2012
Last Updated: June 18, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
Clopidogrel,
Aspirin,
Pharmacogenomics

Additional relevant MeSH terms:
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014