HealthyPhase 1NCT02171598
Investigation of the Impact of Concomitant Use of Multiple Doses of Clopidogrel With Multiple Doses of Dabigatran Etexilate on the Pharmacokinetic and Pharmacodynamic Parameters in Healthy Male Subjects
A Phase 1 study testing Clopidogrel, Dabigatran high dose and Dabigatran low dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The primary objective of the study (Main Part 2) was to investigate whether and to which extent a combination of multiple oral doses (steady state conditions) of 75 mg of clopidogrel q.d. (after a loading dose of 300 mg) and multiple doses of 150 mg of dabigatran etexilate b.i.d. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clopidogrel, Dabigatran high dose and Dabigatran low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jul 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), body temperature, 12-lead electrocardiogram, clinical laboratory tests
- Age ≥18 and Age ≤40 years
- Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Who cannot join
- Any gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:
- Hemorrhagic disorders or bleeding diathesis
- Occult blood in faeces or haematuria
- Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
- History of arteriovenous malformation or aneurysm
Show all 26Show fewer
- History of gastroduodenal ulcer disease, gastrointestinal haemorrhage and haemorrhoids
- History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
- Use of drugs that may interfere with haemostasis during trial conduct (e.g.acetyl salicylic acid or other non-steroidal anti-inflammatory drugs)
- Relevant surgery of gastrointestinal tract
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of any medication within four weeks of first dosing
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within four weeks prior to administration or during the trial, especially inhibitors or inducers of P-gp, CYP3A4 CYP2C9 or CYP2C19
- Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, nonsteroidal anti-rheumatic drugs, cumarin etc. within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Alcohol abuse (more than 60 g/day on a regular basis)
- Drug abuse
- Within 5 days of study medication no intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's Worth
- Blood donation (more than 100 mL within four weeks prior to administration)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- Male subjects do not agree to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two months)
About this study
Official title: Randomised, Open Label, 3-way Cross Over Phase I Study to Investigate the Impact of Concomitant Use of Multiple Doses of Clopidogrel (75 mg qd After a Loading Dose of 300 mg) With Multiple Doses of Dabigatran Etexilate (150 mg Bid) on the Pharmacokinetic and Pharmacodynamic Parameters, and Additionally the Impact of Single Oral Doses of 300 mg and 600 mg of Clopidogrel Administered Under Steady State Conditions of Dabigatran of 75 mg and 150 mg in Healthy Male Subjects
The primary objective of the study (Main Part 2) was to investigate whether and to which extent a combination of multiple oral doses (steady state conditions) of 75 mg of clopidogrel q.d. (after a loading dose of 300 mg) and multiple doses of 150 mg of dabigatran etexilate b.i.d. at steady state affects pharmacokinetic and pharmacodynamic parameters of dabigatran etexilate and clopidogrel.
The objective of the preceding Pilot Part 1 of the study was to explore the effect of a single dose of 300 mg clopidogrel administered after multiple doses of 75 mg and 150 mg dabigatran had reached steady state, regarding safety as well as pharmacokinetic and pharmacodynamic parameters.
The Main Part 3 of the study moreover was to compare intra-individually the effects of a single dose of 600 mg clopidogrel with the same dose, 600 mg clopidogrel, given additionally to multiple doses of 150 mg dabigatran in steady state condition with respect to safety and pharmacokinetic and pharmacodynamic parameters.
- Conditions
- Healthy
- Being tested
- Clopidogrel, Dabigatran high dose, Dabigatran low dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Dabigatran high doseDrug
Dabigatran low doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Fixed sequence 1 | Experimental | multiple-dose, fixed-sequence with 2 periods of 4 days separated by a washout period of at least 14 days. A single dose of 300 mg clopidogrel will be given on top of 75 mg or 150 mg dabigatran in steady state. Receives: Drug: Clopidogrel; Drug: Dabigatran high dose; Drug: Dabigatran low dose |
| Crossover | Experimental | clopidogrel + dabigatran / clopidogrel / dabigatran in randomized order Receives: Drug: Clopidogrel; Drug: Dabigatran high dose; Drug: Dabigatran low dose |
| Fixed sequence 2 | Experimental | intra-individual comparison with the fixed sequence of a single dose of 600mg clopidogrel alone and the combination of dabigatran 150 mg in steady state plus single dose of 600 mg clopidogrel Receives: Drug: Clopidogrel; Drug: Dabigatran high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss (area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state)
for total dabigatran, clopidogrel and the inactive metabolite SR26334
Measured: up to 19 days
AUC0-24,1 (area under the concentration-time curve of the analyte in plasma over one dosing interval after the loading dose)
for clopidogrel and the inactive metabolite SR26334
Measured: up to 19 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
for total dabigatran, clopidogrel and the inactive metabolite SR26334
Measured: up to 19 days
Cmax,1 (maximum measured concentration of the analyte in plasma after the loading dose)
for total dabigatran, clopidogrel and the inactive metabolite SR26334
Measured: up to 19 days
AUECIPA,0-24 (area under the effect curve of inhibition of platelet aggregation after the first dose of clopidogrel)
Measured: up to 19 days
Emax,IPA,0-24 (maximum percentage change - compared to baseline - in adenosine diphosphate-induced platelet aggregation after the loading dose of clopidogrel)
Measured: baseline, up to 19 days
Secondary outcomes (26)
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
AUC0-tz (area under the concentration-time curve of the analyte in plasma from the time point 0 to the last quantifiable analyte plasma concentration)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
λz (terminal rate constant in plasma)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
t1/2 (terminal half-life of the analyte in plasma)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
MRTpo (mean residence time of the analyte in the body after oral administration)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Clopidogrel and SR 26334 after the loading dose
Measured: up to 8 weeks
Cmax, ss
free dabigatran after multiple dosing
Measured: up to 8 weeks
AUCτ,ss
free dabigatran after multiple dosing
Measured: up to 8 weeks
AUC0-tz,ss (area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
tz,ss (time of last measureable concentration of the analyte in plasma within the dosing interval τ at steady state)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state on day 4)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
tmin,ss (time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
PTF (peak trough fluctuation)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
Cavg (average concentration of the analyte in plasma at steady state over a uniform dosing interval)
Clopidogrel and SR 26334; dabigatran (free and total) after multiple dosing
Measured: up to 8 weeks
AUECt1-t2 (area under the effect curve (baseline corrected by ratio))
for activated partial thromboplastin time, thrombin time and ecarin clotting time
Measured: up to 8 weeks
ERmax (maximum effect ratio)
for activated partial thromboplastin time, thrombin time and ecarin clotting time
Measured: up to 8 weeks
tmax (time to maximum effect)
for activated partial thromboplastin time, thrombin time and ecarin clotting time
Measured: up to 8 weeks
Occurence of Adverse Events
Measured: up to 13 weeks
Assessment of Tolerability by investigator
Measured: up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startFeb 2009
- Primary completionJul 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 Boehringer IngelheimThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171598
- Sponsor's protocol ID
- 1160.83
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Open Label, 3-way Cross Over Phase I Study to Investigate the Impact of Concomitant Use of Multiple Doses of Clopidogrel (75 mg qd After a Loading Dose of 300 mg) With Multiple Doses of Dabigatran Etexilate (150 mg Bid) on the Pharmacokinetic and Pharmacodynamic Parameters, and Additionally the Impact of Single Oral Doses of 300 mg and 600 mg of Clopidogrel Administered Under Steady State Conditions of Dabigatran of 75 mg and 150 mg in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02171598
- Acronym / sponsor ID
- 1160.83
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- First posted
- 24 Jun 2014 (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 primary objective of the study (Main Part 2) was to investigate whether and to which extent a combination of multiple oral doses (steady state conditions) of 75 mg of clopidogrel q.d. (after a loading dose of 300 mg) and multiple doses of 150 mg of dabigatran etexilate b.i.d. at steady state affects pharmacokinetic and pharmacodynamic parameters of dabigatran etexilate and clopidogrel.
The objective of the preceding Pilot Part 1 of the study was to explore the effect of a single dose of 300 mg clopidogrel administered after multiple doses of 75 mg and 150 mg dabigatran had reached steady state, regarding safety as well as pharmacokinetic and pharmacodynamic parameters.
The Main Part 3 of the study moreover was to compare intra-individually the effects of a single dose of 600 mg clopidogrel with the same dose, 600 mg clopidogrel, given additionally to multiple doses of 150 mg dabigatran in steady state condition with respect to safety and pharmacokinetic and pharmacodynamic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fixed sequence 1 | Experimental | Drug: Clopidogrel, Drug: Dabigatran high dose, Drug: Dabigatran low dosemultiple-dose, fixed-sequence with 2 periods of 4 days separated by a washout period of at least 14 days. A single dose of 300 mg clopidogrel will be given on top of 75 mg or 150 mg dabigatran in steady state. |
| Crossover | Experimental | Drug: Clopidogrel, Drug: Dabigatran high dose, Drug: Dabigatran low doseclopidogrel + dabigatran / clopidogrel / dabigatran in randomized order |
| Fixed sequence 2 | Experimental | Drug: Clopidogrel, Drug: Dabigatran high doseintra-individual comparison with the fixed sequence of a single dose of 600mg clopidogrel alone and the combination of dabigatran 150 mg in steady state plus single dose of 600 mg clopidogrel |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), body temperature, 12-lead electrocardiogram, clinical laboratory tests
- Age ≥18 and Age ≤40 years
- Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Key exclusion criteria (26 listed)
- Any gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:
- Relevant surgery of gastrointestinal tract
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Clopidogrel | Drug | Crossover, Fixed sequence 1, Fixed sequence 2 |
| Dabigatran high dose | Drug | Crossover, Fixed sequence 1, Fixed sequence 2 |
| Dabigatran low dose | Drug | Crossover, Fixed sequence 1 |
Primary outcome
AUCτ,ss (area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state)
Time frame: up to 19 days
for total dabigatran, clopidogrel and the inactive metabolite SR26334
AUC0-24,1 (area under the concentration-time curve of the analyte in plasma over one dosing interval after the loading dose)
Time frame: up to 19 days
for clopidogrel and the inactive metabolite SR26334
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time frame: up to 19 days
for total dabigatran, clopidogrel and the inactive metabolite SR26334
Cmax,1 (maximum measured concentration of the analyte in plasma after the loading dose)
Time frame: up to 19 days
for total dabigatran, clopidogrel and the inactive metabolite SR26334
AUECIPA,0-24 (area under the effect curve of inhibition of platelet aggregation after the first dose of clopidogrel)
Time frame: up to 19 days
Emax,IPA,0-24 (maximum percentage change - compared to baseline - in adenosine diphosphate-induced platelet aggregation after the loading dose of clopidogrel)
Time frame: baseline, up to 19 days
26 secondary outcomes
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 8 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 8 weeks
AUC0-tz (area under the concentration-time curve of the analyte in plasma from the time point 0 to the last quantifiable analyte plasma concentration)
Time frame: up to 8 weeks
λz (terminal rate constant in plasma)
Time frame: up to 8 weeks
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 8 weeks
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 8 weeks
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 8 weeks
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 8 weeks
Cmax, ss
Time frame: up to 8 weeks
AUCτ,ss
Time frame: up to 8 weeks
AUC0-tz,ss (area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ)
Time frame: up to 8 weeks
tz,ss (time of last measureable concentration of the analyte in plasma within the dosing interval τ at steady state)
Time frame: up to 8 weeks
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state on day 4)
Time frame: up to 8 weeks
CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration)
Time frame: up to 8 weeks
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 8 weeks
tmin,ss (time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 8 weeks
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: up to 8 weeks
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: up to 8 weeks
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration)
Time frame: up to 8 weeks
PTF (peak trough fluctuation)
Time frame: up to 8 weeks
Cavg (average concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: up to 8 weeks
AUECt1-t2 (area under the effect curve (baseline corrected by ratio))
Time frame: up to 8 weeks
ERmax (maximum effect ratio)
Time frame: up to 8 weeks
tmax (time to maximum effect)
Time frame: up to 8 weeks
Occurence of Adverse Events
Time frame: up to 13 weeks
Assessment of Tolerability by investigator
Time frame: up to 13 weeks
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 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clopidogrel, Dabigatran high dose and Dabigatran low dose in people with Healthy, run by Boehringer Ingelheim.
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 4 inclusion and 26 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
AUCτ,ss (area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state) (time frame: up to 19 days). The study lists 6 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 24 Jun 2014.