NCT01129414CompletedPhase 1
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 (600 mg Loading Dose Followed by 150 mg/Day) Alone or Given Concomitantly With Omeprazole 80 mg/Day in Healthy Male and Female Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Study Overview
Brief Summary
Primary objective:
- Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects
Secondary Objective:
- Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole
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 (clopidogrel or omeprazole)
- Period clopidogrel/placebo: 7 days including 5 days treatment
- Period clopidogrel/placebo + omeprazole: 12 days including 10 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy 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 if male, between 40 kg and 85 kg if female, 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 omeprazole
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Arms & Interventions
Group clopidogrel - clopidogrel + omeprazole
Experimental
Period 1:
- Day 1: clopidogrel 600 mg loading dose
- Day 2 to Day 5: clopidogrel 150 mg, once daily
Period 2:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: clopidogrel 600 mg loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: clopidogrel 150 mg + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions
Intervention: Clopidogrel (Drug)
Group clopidogrel - clopidogrel + omeprazole
Experimental
Period 1:
- Day 1: clopidogrel 600 mg loading dose
- Day 2 to Day 5: clopidogrel 150 mg, once daily
Period 2:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: clopidogrel 600 mg loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: clopidogrel 150 mg + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions
Intervention: Omeprazole (Drug)
Group placebo - placebo + omeprazole
Placebo Comparator
Period 1:
- Day 1: placebo loading dose
- Day 2 to Day 5: placebo, once daily
Period 2:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: placebo loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions
Intervention: Placebo (Drug)
Group placebo - placebo + omeprazole
Placebo Comparator
Period 1:
- Day 1: placebo loading dose
- Day 2 to Day 5: placebo, once daily
Period 2:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: placebo loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions
Intervention: Omeprazole (Drug)
Group clopidogrel + omeprazole - clopidogrel
Experimental
Period 1:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: clopidogrel 600 mg loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: clopidogrel 150 mg + omeprazole 80 mg concomitantly, once daily
Period 2:
- Day 1: clopidogrel 600 mg loading dose
- Day 2 to Day 5: clopidogrel 150 mg, once daily
Each intake is under fasted conditions
Intervention: Clopidogrel (Drug)
Group clopidogrel + omeprazole - clopidogrel
Experimental
Period 1:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: clopidogrel 600 mg loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: clopidogrel 150 mg + omeprazole 80 mg concomitantly, once daily
Period 2:
- Day 1: clopidogrel 600 mg loading dose
- Day 2 to Day 5: clopidogrel 150 mg, once daily
Each intake is under fasted conditions
Intervention: Omeprazole (Drug)
Group placebo + omeprazole placebo
Placebo Comparator
Period 1:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: placebo loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: placebo + omeprazole 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
Intervention: Placebo (Drug)
Group placebo + omeprazole placebo
Placebo Comparator
Period 1:
- Day -5 to Day -1: omeprazole 80 mg, once daily
- Day 1: placebo loading dose + omeprazole 80 mg concomitantly
- Day 2 to Day 5: placebo + omeprazole 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
Intervention: Omeprazole (Drug)
Outcomes
Primary Outcomes
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Time Frame: Day 5 of each period
Secondary Outcomes
- Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment(Day 5 of each period)
- Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment(Day 5 of each period)
- Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment(Up to 24 hours postdose on Day 5 for each period)
- Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment(Up to 24 hours postdose on Day 5 for each period)
Investigators
Study Sites (1)
Loading locations...
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