HealthyPhase 1NCT01129271
Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
A Phase 1 study testing clopidogrel in people with Healthy, run by Sanofi at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2009to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
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
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
Read the 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
- Conditions
- Healthy
- Being tested
- clopidogrel, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Pharmaceutical form: tablet
Route of administration: oral
Matching placeboDrug
Pharmaceutical form: tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Group clopidogrel fed - fasting | Experimental | 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 Receives: Drug: clopidogrel |
| Group placebo fed - fasting | Placebo comparator | 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 Receives: Drug: Matching placebo |
| Group clopidogrel fasting - fed | Experimental | 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 Receives: Drug: clopidogrel |
| group placebo fasting -fed | Placebo comparator | 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 Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Measured: Day 5 of each period
Secondary outcomes (3)
Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast
Measured: 6 hours and 24 hours after first dosing of each period
Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment
Measured: up to 24 hours postdose on Day 5 for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment
Measured: up to 24 hours postdose on Day 5 for each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- International Clinical Development Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129271
- Sponsor's protocol ID
- ALI11209
- Status last verified
- Dec 2011
- First submitted
- 21 May 2010
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22128201
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01129271
- Acronym / sponsor ID
- ALI11209
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group clopidogrel fed - fasting | Experimental | Drug: clopidogrelPeriod 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 |
| Group placebo fed - fasting | Placebo comparator | Drug: Matching placeboPeriod 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 |
| Group clopidogrel fasting - fed | Experimental | Drug: clopidogrelPeriod 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 |
| group placebo fasting -fed | Placebo comparator | Drug: Matching placeboPeriod 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrelPharmaceutical form: tablet Route of administration: oral | Drug | Group clopidogrel fasting - fed, Group clopidogrel fed - fasting |
| Matching placeboPharmaceutical form: tablet Route of administration: oral | Drug | Group placebo fed - fasting, group placebo fasting -fed |
Primary outcome
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Time frame: Day 5 of each period
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
- Results publication: PubMed 22128201Hurbin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
International Clinical Development Study Director study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing clopidogrel in people with Healthy, run by Sanofi at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment (time frame: Day 5 of each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2011.