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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Centre d’investigations cliniques, HEGP Service d’hématologie biologique, HEGP Service de pharmacologie, Pitié-Salpétrière |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00413608 |
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
Condition | Intervention | Phase |
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Healthy |
Drug: Clopidogrel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects |
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | April 2009 |
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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean Sébastien HULOT, MD | . +33(0)-1-42-16-16-71 | jean-sebastien.hulot@psl.aphp.fr |
France | |
Hôpital Européen Georges Pompidou | Recruiting |
PARIS, France, 75015 | |
Contact: Jean Sébastien HULOT, MD +33(0)-1-42-16-16-71 jean-sebastien.hulot@psl.aphp.fr |
Principal Investigator: | Jean Sébastien HULOT, MD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P060309 |
Study First Received: | December 19, 2006 |
Last Updated: | July 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00413608 |
Health Authority: | France: Ministry of Health |
Human Adults Male Alleles Genotype Platelet Aggregation/drug effects |
Platelet Aggregation Inhibitors/*pharmacology Platelet Function Tests Pharmacogenetics *Polymorphism, Genetic Ticlopidine/*analogs & derivatives/pharmacology Healthy subjects |
Ticlopidine Clopidogrel Healthy |
Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Pharmacologic Actions |