HealthyPhase 1NCT01123824
Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects
A Phase 1 study testing CLOPIDOGREL in people with Healthy, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects Secondary Objectives: Assess the… Read more about this study
- Who is it for?
- Ages 18 to 65 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?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Aug 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject in good health, as determined by a medical history, physical examination including vital signs and clinical laboratory tests:
- with a body weight between 45 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
- classified into one of the 4 groups of metabolizers according to his/her CYP2C19 genotype:
- Ultrarapid Metabolizers (UMs, CYP2C19*1/*17 and CYP2C19*17/*17)
- homozygous Extensive Metabolizers (homoEMs, CYP2C19*1/*1)
- heterozygous Extensive Metabolizers (heteroEMs, CYP2C19*1/*2 and CYP2C19*1/*3)
- Poor Metabolizers (PMs, CYP2C19*2/*2 and CYP2C19*2/*3)
Who cannot join
- Evidence of inherited disorder of coagulation/hemostasis functions
- Subject smoking more than 10 cigarettes or equivalent per day
- Unability to abstain from intake of any drug affecting hemostasis 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: A Randomized, Double-blind, Double-dummy, Two Period, Two Treatment Cross-over Pharmacodynamic and Pharmacokinetic Study of Clopidogrel Given as 5-day Repeated Oral Doses (300 mg Loading Dose Followed by 75 mg/Day and 600 mg Loading Dose Followed by 150 mg/Day) in 4 Different Groups of CYP2C19 Genotyped Healthy Male and Female Subjects
Primary Objective:
- Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects
Secondary Objectives:
- Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days)
- Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen
Read the detailed description
The total study duration per subject is 10-12 weeks broken down as follows:
- Screening: 2 to 40 days before the first dosing
- Period 1: 7 days including 5 days treatment
- Washout: At least 14 days after the last dosing
- Period 2: 7 days including 5 days treatment
- End of study: 7 to 10 days after the last dosing
- Conditions
- Healthy
- Being tested
- CLOPIDOGREL, placebo
- Keywords
- healthy subjects
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: tablets
Route of administration: oral
placeboDrug
Pharmaceutical form: matching tablets
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence clopidogrel 300/75 mg - 600/150 mg | Experimental | Period 1:
* Day 1: clopidogrel, 300 mg loading dose + placebo
* Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Period 2:
* Day 1: clopidogrel, 600 mg loading dose
* Day 2 to Day 5: clopidogrel, 150 mg, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours Receives: Drug: CLOPIDOGREL; Drug: placebo |
| Sequence clopidogrel 600/150 mg - 300/75 mg | Experimental | Period 1:
* Day 1: clopidogrel, 600 mg loading dose
* Day 2 to Day 5: clopidogrel, 150 mg, once daily
Period 2:
* Day 1: clopidogrel, 300 mg loading dose + placebo
* Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours Receives: Drug: CLOPIDOGREL; Drug: 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) 5 µM after 5 days treatment
Measured: Day 5 of each period
Secondary outcomes (3)
Maximum platelet aggregation intensity (MAI) induced by ADP 20 µM after 5 days treatment
Measured: Day 5 of each period
Platelet reactivity index -Vasodilator-stimulated phosphoprotein test (PRI-VASP) after 5 days treatment
Measured: Day 5 of each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, tmax, AUC0-24, AUClast) 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 posted14 May 2010 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 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
- 40 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 chair, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123824
- Sponsor's protocol ID
- PKD11147
- Other IDs
- 2009-010105-37, 2009
- Status last verified
- Dec 2011
- First submitted
- 12 May 2010
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Simon T, Bhatt DL, Bergougnan L, Farenc C, Pearson K, Perrin L, Vicaut E, Lacreta F, Hurbin F, Dubar M. Genetic polymorphisms and the impact of a higher clopidogrel dose regimen on active metabolite exposure and antiplatelet response in healthy subjects. Clin Pharmacol Ther. 2011 Aug;90(2):287-95. doi: 10.1038/clpt.2011.127. Epub 2011 Jun 29.
PubMed 21716274
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, Double-blind, Double-dummy, Two Period, Two Treatment Cross-over Pharmacodynamic and Pharmacokinetic Study of Clopidogrel Given as 5-day Repeated Oral Doses (300 mg Loading Dose Followed by 75 mg/Day and 600 mg Loading Dose Followed by 150 mg/Day) in 4 Different Groups of CYP2C19 Genotyped Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01123824
- Acronym / sponsor ID
- PKD11147
- Conditions
- Healthy
- Keywords
- healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 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 possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects
Secondary Objectives:
- Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days)
- Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen
Detailed description
The total study duration per subject is 10-12 weeks broken down as follows:
- Screening: 2 to 40 days before the first dosing
- Period 1: 7 days including 5 days treatment
- Washout: At least 14 days after the last dosing
- Period 2: 7 days including 5 days treatment
- 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence clopidogrel 300/75 mg - 600/150 mg | Experimental | Drug: CLOPIDOGREL, Drug: placeboPeriod 1: * Day 1: clopidogrel, 300 mg loading dose + placebo * Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily Period 2: * Day 1: clopidogrel, 600 mg loading dose * Day 2 to Day 5: clopidogrel, 150 mg, once daily Each intake is at around 8:00 AM fasted for at least 10 hours |
| Sequence clopidogrel 600/150 mg - 300/75 mg | Experimental | Drug: CLOPIDOGREL, Drug: placeboPeriod 1: * Day 1: clopidogrel, 600 mg loading dose * Day 2 to Day 5: clopidogrel, 150 mg, once daily Period 2: * Day 1: clopidogrel, 300 mg loading dose + placebo * Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily Each intake is at around 8:00 AM fasted for at least 10 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subject in good health, as determined by a medical history, physical examination including vital signs and clinical laboratory tests:
- with a body weight between 45 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
- classified into one of the 4 groups of metabolizers according to his/her CYP2C19 genotype:
Key exclusion criteria (4 listed)
- Evidence of inherited disorder of coagulation/hemostasis functions
- Subject smoking more than 10 cigarettes or equivalent per day
- Unability to abstain from intake of any drug affecting hemostasis 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.
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: tablets Route of administration: oral | Drug | Sequence clopidogrel 300/75 mg - 600/150 mg, Sequence clopidogrel 600/150 mg - 300/75 mg |
| placeboPharmaceutical form: matching tablets Route of administration: oral | Drug | Sequence clopidogrel 300/75 mg - 600/150 mg, Sequence clopidogrel 600/150 mg - 300/75 mg |
Primary outcome
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5 µM after 5 days treatment
Time frame: Day 5 of each period
3 secondary outcomes
Maximum platelet aggregation intensity (MAI) induced by ADP 20 µM after 5 days treatment
Time frame: Day 5 of each period
Platelet reactivity index -Vasodilator-stimulated phosphoprotein test (PRI-VASP) after 5 days treatment
Time frame: Day 5 of each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, tmax, AUC0-24, AUClast) 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 21716274Simon T, Bhatt DL, Bergougnan L, Farenc C, Pearson K, Perrin L, Vicaut E, Lacreta F, Hurbin F, Dubar M. Genetic polymorphisms and the impact of a higher clopidogrel dose regimen on active metabolite exposure and antiplatelet response in healthy subjects. Clin Pharmacol Ther. 2011 Aug;90(2):287-95. doi: 10.1038/clpt.2011.127. Epub 2011 Jun 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 chair
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 Germany.
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 7 inclusion and 4 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 1 site in Germany. 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?
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5 µM 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 NCT01123824, 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.