Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00413608

First received: December 19, 2006

Last updated: May 4, 2011

Last verified: July 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2006

Last Updated Date

May 4, 2011

Start Date ^ICMJE

January 2007

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Inhibition platelet activity index (ADP induced aggregation) measured between [ Time Frame: during 7 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Inhibition platelet activity index (ADP induced aggregation) measured between
baseline and at the end of the each period

Change History

Complete list of historical versions of study NCT00413608 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clopidogrel and metabolites pharmacokinetics and relation to dynamics [ Time Frame: during 7 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Clopidogrel and metabolites pharmacokinetics and relation to dynamics

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects

Official Title ^ICMJE

Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects

Brief Summary

To test pharmacodynamic response to clopidogrel 150mg once daily during 7 days in healthy subjects carriers of a mutated allele (*2) associated with CYP2C19 deficiency and non responders to the usual regimen of 75 mg once daily

Detailed Description

Thirty individuals genotyped for specific variants of 2C19 cytochrome and P2Y12 platelet ADP receptor will receive during one week a daily dose of 75 mg of clopidogrel. Depending on their pharmacodynamic response to this dose of clopidogrel, subjects will be affiliated to two groups, "good responders" and "bad responders". After a wash-out period, "bad responders" will receive a double dose of clopidogrel, while the "good responders" will receive 75 mg of clopidogrel, associated with a CYP2C19 inhibitor. Such study will allow to evaluate both the impact of raising daily dose of clopidogrel in patients with defected variants of 2C19 and potential interactions of clopidogrel with other drugs.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Clopidogrel

Clopidogrel

Other Name: Clopidogrel

Study Arm (s)

Experimental: 1
Clopidogrel

Intervention: Drug: Clopidogrel
Experimental: 2
Clopidogrel

Intervention: Drug: Clopidogrel

Publications *

Hulot JS, Bura A, Villard E, Azizi M, Remones V, Goyenvalle C, Aiach M, Lechat P, Gaussem P. Cytochrome P450 2C19 loss-of-function polymorphism is a major determinant of clopidogrel responsiveness in healthy subjects. Blood. 2006 Oct 1;108(7):2244-7. Epub 2006 Jun 13.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteers, aged 18 to 35, non smoker, of caucasian origin
Compatible 2C19 and P2Y12 genotypes
Weight 60 kg to 100 kg, and normal BMI
Standard laboratory investigations normal
Negative testing for HIV infection and B and C hepatitis
Basal platelet agregation testing normal
EKG, blood pressure and cardiac frequency in normal range
Ability to understand, follow and sign the protocol

Exclusion Criteria:

Evolutive medical affection, even treated
Medical history of allergic response to medication or other, peptic ulcer, or known hemorrhagic disorder
Laboratory testing out of normal range
Subjects practicing violent sports
Unability to understand or follow the protocol

Gender

Male

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00413608

Other Study ID Numbers ^ICMJE

P060309

Has Data Monitoring Committee

Responsible Party

Yannick VACHER, Department Clinical Research of developpement

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean Sébastien HULOT, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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