Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01129271
First received: May 21, 2010
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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

Condition Intervention Phase
Healthy
Drug: clopidogrel
Drug: Matching placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment [ Time Frame: Day 5 of each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast [ Time Frame: 6 hours and 24 hours after first dosing of each period ] [ Designated as safety issue: No ]
  • Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment [ Time Frame: up to 24 hours postdose on Day 5 for each period ] [ Designated as safety issue: No ]
  • Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment [ Time Frame: up to 24 hours postdose on Day 5 for each period ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group clopidogrel fed - fasting

Period 1:

  • Day 1: clopidogrel 300 mg loading dose with high fat breakfast
  • Day 2 to Day 5: clopidogrel 75 mg/day with standard breakfast, once daily

Period 2:

  • Day 1: clopidogrel 300 mg loading dose under fasted conditions
  • Day 2 to Day 5: clopidogrel 75 mg/day under fasted conditions, once daily
Drug: clopidogrel

Pharmaceutical form: tablet

Route of administration: oral

Placebo Comparator: Group placebo fed - fasting

Period 1:

  • Day 1: placebo loading dose with high fat breakfast
  • Day 2 to Day 5: placebo with standard breakfast, once daily

Period 2:

  • Day 1: placebo loading dose under fasted conditions
  • Day 2 to Day 5: placebo under fasted conditions, once daily
Drug: Matching placebo

Pharmaceutical form: tablet

Route of administration: oral

Experimental: Group clopidogrel fasting - fed

Period 1:

  • Day 1: clopidogrel 300 mg loading dose under fasted conditions
  • Day 2 to Day 5: clopidogrel 75 mg/day under fasted conditions, once daily

Period 2:

  • Day 1: clopidogrel 300 mg loading dose with high fat breakfast
  • Day 2 to Day 5: clopidogrel 75 mg/day with standard breakfast, once daily
Drug: clopidogrel

Pharmaceutical form: tablet

Route of administration: oral

Placebo Comparator: group placebo fasting -fed

Period 1:

  • Day 1: placebo loading dose under fasted conditions
  • Day 2 to Day 5: placebo in fasted conditions, once daily

Period 2:

  • Day 1: placebo loading dose with high fat breakfast
  • Day 2 to Day 5: placebo with standard breakfast, once daily
Drug: Matching placebo

Pharmaceutical form: tablet

Route of administration: oral


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129271

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: International Clinical Development Study Director Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01129271     History of Changes
Other Study ID Numbers: ALI11209
Study First Received: May 21, 2010
Last Updated: December 14, 2011
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014