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

NCT01503658 | Completed Phase 4

• 1 other identifier: PGX_Clopidogrel_001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;

• 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
• 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

Keywords

Clopidogrel,; Aspirin,; Pharmacogenomics

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics of Clopidogrel

  Plasma concentration of clopidogrel and active metabolite 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

• Pharmacodynamics of clopidogrel

  Relative inhibition of platelet aggregation by aggregometer or VerifyNow

  Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29

Secondary Outcomes (1)

• mRNA/microRNA/endogenous metabolite

  predose on Day 1, Day 8, Day 15, Day 22 and Day 29

Study Arms (1)

Clopidogrel+Aspirin

EXPERIMENTAL

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

Interventions

Clopidogrel+Aspirin DRUG

Clopidogrel 75 mg, Aspirin 100 mg

Clopidogrel+Aspirin

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male subjects aged 20 - 45 years.
• \. 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).
• \. 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.

You may not qualify if:

• \. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel or aspirin)
• \. Clinically relevant abnormal medical history that could interfere with the objectives of the study.
• \. 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.
• \. 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.
• \. A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
• \. Presence or history of drug abuse or positive result in urine drug screening test.
• \. Participation in other clinical trial within 2 months before first dose.
• \. Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
• \. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
• Use of grapefruit juice within 1 week before first dose.
• \. Blood donation during 2 months or apheresis during 1 month before the study.
• \. Use of alcohol over 21 units/weeks
• \. Smoking of more than 10 cigarettes/days within 3 months before first dose.
• \. Subject judged not eligible for study participation by investigator.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital Clinical Trials Center

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24566733 DERIVED

Study Officials

• In-Jin Jang, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2012
• First Posted: January 4, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

KR (1)