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

Phase 4

Completed

• Conditions: Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel; Influence of Aspirin on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
• Interventions: Drug: Clopidogrel+Aspirin

• Registration Number: NCT01503658
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-01
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel+Aspirin	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Clopidogrel	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	Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29	Relative inhibition of platelet aggregation by aggregometer or VerifyNow

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trials Center; 🇰🇷 Seoul, Korea, Republic of