Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of ClopidogrelPhase 4NCT01503658

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

A Phase 4 study testing Clopidogrel+Aspirin in people with Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel and Influence of Aspirin on the Pharmacokinetics/Pharmacodynamics of Clopidogrel, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel, Influence of Aspirin on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
What is being tested?: Clopidogrel+Aspirin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteSouth Korea
Study dates: Jan 2012to May 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital Clinical Trials Center
Seoul, 110-744

Other trials in South Korea

About this study

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

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

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

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
Being tested: Clopidogrel+Aspirin
Keywords: Clopidogrel,, Aspirin,, Pharmacogenomics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clopidogrel+AspirinDrug
Clopidogrel 75 mg, Aspirin 100 mg

Study groups in NCT01503658
Study group	Role	What they receive
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 Receives: Drug: Clopidogrel+Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics of Clopidogrel
Plasma concentration of clopidogrel and active metabolite of clopidogrel
Measured: 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
Measured: Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012May 2012

First posted4 Jan 2012 (estimated)
Study startJan 2012
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of ClopidogrelStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01503658
Sponsor's protocol ID: PGX_Clopidogrel_001
Status last verified: Jun 2012
First submitted: 1 Jan 2012
Last updated: 19 Jun 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 24566733

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01503658
Acronym / sponsor ID: PGX_Clopidogrel_001
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Jan 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 4 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

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

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Clopidogrel+Aspirin	Experimental	Drug: Clopidogrel+AspirinClopidogrel on Day 1, Aspirin on Day 2 - Day 14, Clopidogrel + Aspirin Day 15, Aspirin on Day 16 - Day 28, Clopidogrel + Aspirin Day 29

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clopidogrel+AspirinClopidogrel 75 mg, Aspirin 100 mg	Drug	Clopidogrel+Aspirin

Primary outcome

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

1 secondary outcome

mRNA/microRNA/endogenous metabolite
Time frame: predose on Day 1, Day 8, Day 15, Day 22 and Day 29

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
Derived from this study: PubMed 24566733Oh 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

In-Jin Jang, MD principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01503658, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.