Clinical trial NCT01129271: Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
Official title: A Randomized, Placebo-controlled, Two-sequence, Two-period Crossover Study, to Investigate a Potential Food Effect on the Pharmacodynamic and Bioavailability of Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-05-24
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Primary objective:

* Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) in healthy subjects

Secondary objectives are to investigate the potential food effect on:

* ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel
* Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated doses of clopidogrel

Detailed description: The total duration per subject is 8-9 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing
* Fed period: 7 days including 5 treatment days
* Washout: at least 14 days after last dosing
* Fasted period: 7 days including 5 treatment days
* End of study: 7 to 10 days after the last dosing

Eligibility criteria: Inclusion Criteria:

Healthy male subjects:

* as determined by medical history, physical examination including vital signs and clinical laboratory tests
* with a body weight between 50kg and 95 kg and a Body Mass Index (BMI) between 18 and 30 kg/m2

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Any contraindication to clopidogrel
* Unability to abstain from intake of any drug affecting haemostasis 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.

Primary outcomes:
measure: Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
timeFrame: Day 5 of each period
Secondary outcomes:
measure: Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast
timeFrame: 6 hours and 24 hours after first dosing of each period
measure: Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment
timeFrame: up to 24 hours postdose on Day 5 for each period
measure: Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment
timeFrame: up to 24 hours postdose on Day 5 for each period
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: International Clinical Development Study Director
role: STUDY_DIRECTOR
References:
citation: Hurbin F, Boulenc X, Daskalakis N, Farenc C, Taylor T, Bonneau D, Lacreta F, Cheng S, Sultan E. Clopidogrel pharmacodynamics and pharmacokinetics in the fed and fasted state: a randomized crossover study of healthy men. J Clin Pharmacol. 2012 Oct;52(10):1506-15. doi: 10.1177/0091270011419852. Epub 2011 Nov 29.