Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects | RxWiki

Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects

Overview[ - collapse ][ - ]

Purpose	Primary objective: - Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with pantoprazole 80 mg/day compared to given alone in healthy male subjects - Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole Secondary Objective: - Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole
Condition	Healthy
Intervention	Drug: Clopidogrel Drug: Placebo Drug: Pantoprazole
Phase	Phase 1
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT01129427
First Received	May 21, 2010
Last Updated	December 14, 2011
Last verified	December 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 21, 2010
Last Updated Date	December 14, 2011
Start Date	August 2009
Estimated Primary Completion Date	November 2009
Current 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] Clopidogrel active metabolite 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 of each period] [Designated as safety issue: No]
Current Secondary Outcome Measures	Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment [Time Frame: Day 5 of each period] [Designated as safety issue: No] Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment [Time Frame: Day 5 of each period] [Designated as safety issue: No] Clopidogrel 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects
Official Title	A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given Concomitantly With Pantoprazole 80 mg/Day in Healthy Male Subjects
Brief Summary	Primary objective: - Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with pantoprazole 80 mg/day compared to given alone in healthy male subjects - Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole Secondary Objective: - Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole
Detailed Description	The total study duration per subjects is 8 - 9 weeks broken down as follows: - Screening: 2 to 21 days before the first dosing - Period clopidogrel/placebo: 7 days including 5 days treatment - Period clopidogrel/placebo + pantoprazole: 14 days including 12 days treatment - Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment - End of study: 7 to 10 days after the last dosing
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Condition	Healthy
Intervention	Drug: Clopidogrel Pharmaceutical form: tablet Route of administration: oral Other Names: SR25990Drug: Placebo Pharmaceutical form: matching tablet Route of administration: oral Drug: Pantoprazole Pharmaceutical form: delayed-release tablet Route of administration: oral Other Names: PROTONIX
Study Arm (s)	Experimental: Group clopidogrel - clopidogrel + pantoprazole Period 1: Day 1: clopidogrel 300 mg loading dose Day 2 to Day 5: clopidogrel 75 mg, once daily Period 2: Day -7 to Day -1: pantoprazole 80 mg, once daily Day 1: clopidogrel 300 mg loading dose + pantoprazole 80 mg concomitantly Day 2 to Day 5: clopidogrel 75 mg + pantoprazole 80 mg concomitantly, once daily Each intake is under fasted conditions. Placebo Comparator: Group placebo - placebo + pantoprazole Period 1: Day 1: placebo loading dose Day 2 to Day 5: placebo, once daily Period 2: Day -7 to Day -1: pantoprazole 80 mg, once daily Day 1: placebo loading dose + pantoprazole 80 mg concomitantly Day 2 to Day 5: placebo + pantoprazole 80 mg concomitantly, once daily Each intake is under fasted conditions. Experimental: Group clopidogrel + pantoprazole - clopidogrel Period 1: Day -7 to Day -1: pantoprazole 80 mg, once daily Day 1: clopidogrel 300 mg loading dose + pantoprazole 80 mg concomitantly Day 2 to Day 5: clopidogrel 75 mg + pantoprazole 80 mg concomitantly, once daily Period 2: Day 1: clopidogrel 300 mg loading dose Day 2 to Day 5: clopidogrel 75 mg, once daily Each intake is under fasted conditions. Placebo Comparator: Group placebo + pantoprazole placebo Period 1: Day -7 to Day -1: pantoprazole 80 mg, once daily Day 1: placebo loading dose + pantoprazole 80 mg concomitantly Day 2 to Day 5: placebo + pantoprazole 80 mg concomitantly, once daily Period 2: Day 1: placebo loading dose Day 2 to Day 5: placebo, once daily Each intake is under fasted conditions.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	66
Estimated Completion Date	November 2009
Estimated Primary Completion Date	November 2009
Eligibility Criteria	Inclusion Criteria: Healthy male subject: - as determined by medical history, physical examination including vital signs and clinical laboratory tests: - with a body weight between 50 kg and 95 kg and with 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 - Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration - Any contraindication to clopidogrel and/or pantoprazole The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gender	Male
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01129427
Other Study ID Numbers	INT11374
Has Data Monitoring Committee	No
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Bristol-Myers Squibb
Investigators	Study Director: International Clinical Development Study Director Sanofi
Verification Date	December 2011

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