Status:
COMPLETED
Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
PHASE1
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...
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 pharmacodyna...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00413608
Start Date
January 1 2007
End Date
January 1 2009
Last Update
May 5 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Européen Georges Pompidou
Paris, France, 75015