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

NCT ID: NCT01503658

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

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

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

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Clopidogrel+Aspirin

Intervention Type: DRUG

Clopidogrel 75 mg, Aspirin 100 mg

Interventions

Clopidogrel+Aspirin

Clopidogrel 75 mg, Aspirin 100 mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

In-Jin Jang, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Jin Jang, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital Clinical Trials Center

Seoul, , South Korea

Countries

South Korea

References

Oh J, Shin D, Lim KS, Lee S, Jung KH, Chu K, Hong KS, Shin KH, Cho JY, Yoon SH, Ji SC, Yu KS, Lee H, Jang IJ. Aspirin decreases systemic exposure to clopidogrel through modulation of P-glycoprotein but does not alter its antithrombotic activity. Clin Pharmacol Ther. 2014 Jun;95(6):608-16. doi: 10.1038/clpt.2014.49. Epub 2014 Feb 24.

Reference Type: DERIVED

PMID: 24566733 (View on PubMed)

Other Identifiers

PGX_Clopidogrel_001

Identifier Type: -

Identifier Source: org_study_id