Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects
NCT ID: NCT01123824
Last Updated: 2011-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2009-04-30
2009-08-31
Brief Summary
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* Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects
Secondary Objectives:
* Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days)
* Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen
Detailed Description
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* Screening: 2 to 40 days before the first dosing
* Period 1: 7 days including 5 days treatment
* Washout: At least 14 days after the last dosing
* Period 2: 7 days including 5 days treatment
* End of study: 7 to 10 days after the last dosing
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Sequence clopidogrel 300/75 mg - 600/150 mg
Period 1:
* Day 1: clopidogrel, 300 mg loading dose + placebo
* Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Period 2:
* Day 1: clopidogrel, 600 mg loading dose
* Day 2 to Day 5: clopidogrel, 150 mg, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours
CLOPIDOGREL
Pharmaceutical form: tablets
Route of administration: oral
placebo
Pharmaceutical form: matching tablets
Route of administration: oral
Sequence clopidogrel 600/150 mg - 300/75 mg
Period 1:
* Day 1: clopidogrel, 600 mg loading dose
* Day 2 to Day 5: clopidogrel, 150 mg, once daily
Period 2:
* Day 1: clopidogrel, 300 mg loading dose + placebo
* Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours
CLOPIDOGREL
Pharmaceutical form: tablets
Route of administration: oral
placebo
Pharmaceutical form: matching tablets
Route of administration: oral
Interventions
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CLOPIDOGREL
Pharmaceutical form: tablets
Route of administration: oral
placebo
Pharmaceutical form: matching tablets
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with a body weight between 45 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²
* classified into one of the 4 groups of metabolizers according to his/her CYP2C19 genotype:
* Ultrarapid Metabolizers (UMs, CYP2C19\*1/\*17 and CYP2C19\*17/\*17)
* homozygous Extensive Metabolizers (homoEMs, CYP2C19\*1/\*1)
* heterozygous Extensive Metabolizers (heteroEMs, CYP2C19\*1/\*2 and CYP2C19\*1/\*3)
* Poor Metabolizers (PMs, CYP2C19\*2/\*2 and CYP2C19\*2/\*3)
Exclusion Criteria
* Subject smoking more than 10 cigarettes or equivalent per day
* Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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International Clinical Development Study Director
Role: STUDY_CHAIR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Berlin, , Germany
Countries
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References
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Simon T, Bhatt DL, Bergougnan L, Farenc C, Pearson K, Perrin L, Vicaut E, Lacreta F, Hurbin F, Dubar M. Genetic polymorphisms and the impact of a higher clopidogrel dose regimen on active metabolite exposure and antiplatelet response in healthy subjects. Clin Pharmacol Ther. 2011 Aug;90(2):287-95. doi: 10.1038/clpt.2011.127. Epub 2011 Jun 29.
Other Identifiers
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2009-010105-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PKD11147
Identifier Type: -
Identifier Source: org_study_id