HealthyPhase 1NCT01129063
Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects
A Phase 1 study testing Clopidogrel in people with Healthy, run by Sanofi at 1 site in France.
Trial summary
The objectives of the study are to: Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects Assess the pharmacokinetic profiles of the clopidogrel and its… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy 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?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects:
- as determined by medical history and complete physical examination including vital signs and clinical laboratory tests
- with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 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
1 site in 1 country.
About this study
Official title: An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects
The objectives of the study are to:
- Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
- Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel
Read the detailed description
The total study duration per subject is 4 - 6 weeks broken down as follows:
- Screening: 2 to 21 days before the first dosing
- Period 1, 2 and 3: 4 days including 1 treatment day each
- Washout between periods: at least 7 days between 2 administrations
- End of study: 7 to 10 days after the last dosing
- Conditions
- Healthy
- Being tested
- Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called SR25990
Pharmaceutical form : tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence clopidogrel 75 / 75 / 300 mg | Experimental | Period 1: clopidogrel 75 mg single dose
Period 2: clopidogrel 75 mg single dose
Period 3: clopidogrel 300 mg single dose
Each intake is at around 8:00 AM under fasted conditions. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
Measured: Up to 48 hours postdose for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC)
Measured: Up to 48 hours postdose for each period
Secondary outcomes (2)
Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z))
Measured: Up to 48 hours postdose for each period
Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z)
Measured: Up to 48 hours postdose 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 startMar 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- International Clinical Development Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129063
- Sponsor's protocol ID
- PKM11086
- Other IDs
- 2008-008450-22, 2008
- Status last verified
- Aug 2010
- First submitted
- 21 May 2010
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01129063
- Acronym / sponsor ID
- PKM11086
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 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.
The objectives of the study are to:
- Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
- Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel
Detailed description
The total study duration per subject is 4 - 6 weeks broken down as follows:
- Screening: 2 to 21 days before the first dosing
- Period 1, 2 and 3: 4 days including 1 treatment day each
- Washout between periods: at least 7 days between 2 administrations
- End of study: 7 to 10 days after the last dosing
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequence clopidogrel 75 / 75 / 300 mg | Experimental | Drug: ClopidogrelPeriod 1: clopidogrel 75 mg single dose Period 2: clopidogrel 75 mg single dose Period 3: clopidogrel 300 mg single dose Each intake is at around 8:00 AM under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- as determined by medical history and complete physical examination including vital signs and clinical laboratory tests
- with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 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 |
|---|---|---|
| ClopidogrelAlso: SR25990Pharmaceutical form : tablet Route of administration: oral | Drug | Sequence clopidogrel 75 / 75 / 300 mg |
Primary outcome
Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
Time frame: Up to 48 hours postdose for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC)
Time frame: Up to 48 hours postdose for each period
2 secondary outcomes
Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z))
Time frame: Up to 48 hours postdose for each period
Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z)
Time frame: Up to 48 hours postdose 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 30 Aug 2010.
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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
1 site in 1 country: 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 1 site in France.
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 30 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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?
Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC)) (time frame: Up to 48 hours postdose for each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2010.