HealthyPhase 1NCT02171559
Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers
A Phase 1 study testing Enoxaparin prefilled syringes and Dabigatran etexilate capsules in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the relative bioavailability and the pharmacodynamics of dabigatran after switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone 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?
- Enoxaparin prefilled syringes and Dabigatran etexilate capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Sep 2008
- 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
- Subjects were healthy males and females based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
- Age ≥18 to ≤55 years
- Body mass index (BMI) ≥18.5 to ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute blood coagulation defect
- 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
Show all 23Show fewer
- History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
- Intake of any medication within 2 weeks of first dosing, especially intake of medication, which influences blood clotting, i.e. acetylsalicylic acid, cumarin etc.
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 4 weeks prior to administration or during the trial
- Alcohol abuse (more than 60 g/day for males and more than 20 g/day for females)
- Drug abuse
- Intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's wort within 5 days of first dosing
- Participation in another trial with an investigational drug within 2 months prior to trial drug administration or during the trial
- Blood donation (more than 100 mL within 4 weeks prior to trial drug administration or during the trial)
- Excessive physical activities (within 1 week prior to trial drug administration or during the trial)
- Any laboratory value outside the reference range that was of clinical relevance
- Inability to comply with dietary regimen of study centre
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- For female subjects:
- Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month after study completion
- No adequate contraception during the study and within 1 month after study completion such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who did not have a vasectomised partner, were not sexually abstinent or surgically sterile, were asked to additionally use a barrier contraception method (e.g. condom, diaphragm with spermicide)
- Lactation period
About this study
Official title: Relative Bioavailability and Pharmacodynamics of Dabigatran After a Single Dose of 220 mg Dabigatran Etexilate and After 40 mg Enoxaparin s.c. for 3 Days Followed by a Single Dose of 220 mg Dabigatran Etexilate in Healthy Male and Female Volunteers (an Open-label, Randomised, Single and Multiple Dose, Two Way Crossover Phase I Study)
To investigate the relative bioavailability and the pharmacodynamics of dabigatran after switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone
- Conditions
- Healthy
- Being tested
- Enoxaparin prefilled syringes, Dabigatran etexilate capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin prefilled syringesDrug
Dabigatran etexilate capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate capsules after enoxaparin ampoules | Experimental | Not described Receives: Drug: Enoxaparin prefilled syringes; Drug: Dabigatran etexilate capsules |
| Dabigatran etexilate capsules without enoxaparin | Active comparator | Not described Receives: Drug: Dabigatran etexilate capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of dabigatran
Measured: Up to 48 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax ) of dabigatran
Measured: Up to 48 hours after drug administration
Area under the effect-time curve of the analyte in plasma over the time interval from 0 to 48 h after administration (AUEC0-48) after dabigatran alone and after dabigatran following enoxaparin administration
Measured: Up to 48 hours after drug administration
Maximum effect ratio to baseline (ERmax) after dabigatran alone and after dabigatran following enoxaparin administration
Measured: Baseline and up to 48 hours after drug administration
Secondary outcomes (18)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) of dabigatran
Measured: Up to 48 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax) of dabigatran
Measured: Up to 48 hours after drug administration
Terminal rate constant in plasma (λz) of dabigatran
Measured: Up to 48 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2) of dabigatran
Measured: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo) of dabigatran
Measured: Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after extravascular administration (CL/F) of dabigatran
Measured: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular administration (Vz/F) of dabigatran
Measured: Up to 48 hours after drug administration
Anti-FIIa activity for Dabigatran etexilate
Measured: Up to 48 hours after drug administration
Anti-FXa/anti-FIIa activity for Enoxaparin
Measured: Up to 48 hours after drug administration
Activated partial thromboplastin time (aPTT) for Dabigatran etexilate
Measured: Up to 48 hours after drug administration
Ecarin clotting time (ECT) for Dabigatran etexilate
Measured: Up to 48 hours after drug administration
Thrombin time (TT) for Dabigatran etexilate
Measured: Up to 48 hours after drug administration
Change in vital signs (blood pressure, pulse rate)
Measured: up to day 61
Change in 12-lead electrocardiogram (ECG)
Measured: up to day 61
Change in clinical laboratory tests
Measured: up to day 61
Occurrence of adverse events
Measured: Up to day 61
Assessment of global tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Measured: Day 61
Assessment of local tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Measured: day 3 of enoxaparin administration
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 startAug 2008
- Primary completionSep 2008
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
- 29 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
- NCT02171559
- Sponsor's protocol ID
- 1160.78
- 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
- Relative Bioavailability and Pharmacodynamics of Dabigatran After a Single Dose of 220 mg Dabigatran Etexilate and After 40 mg Enoxaparin s.c. for 3 Days Followed by a Single Dose of 220 mg Dabigatran Etexilate in Healthy Male and Female Volunteers (an Open-label, Randomised, Single and Multiple Dose, Two Way Crossover Phase I Study)
- ClinicalTrials.gov ID
- NCT02171559
- Acronym / sponsor ID
- 1160.78
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (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.
To investigate the relative bioavailability and the pharmacodynamics of dabigatran after switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate capsules after enoxaparin ampoules | Experimental | Drug: Enoxaparin prefilled syringes, Drug: Dabigatran etexilate capsules |
| Dabigatran etexilate capsules without enoxaparin | Active comparator | Drug: Dabigatran etexilate capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects were healthy males and females based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
- Age ≥18 to ≤55 years
- Body mass index (BMI) ≥18.5 to ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Key exclusion criteria (23 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute blood coagulation defect
- 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 |
|---|---|---|
| Enoxaparin prefilled syringes | Drug | Dabigatran etexilate capsules after enoxaparin ampoules |
| Dabigatran etexilate capsules | Drug | Dabigatran etexilate capsules after enoxaparin ampoules, Dabigatran etexilate capsules without enoxaparin |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of dabigatran
Time frame: Up to 48 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax ) of dabigatran
Time frame: Up to 48 hours after drug administration
Area under the effect-time curve of the analyte in plasma over the time interval from 0 to 48 h after administration (AUEC0-48) after dabigatran alone and after dabigatran following enoxaparin administration
Time frame: Up to 48 hours after drug administration
Maximum effect ratio to baseline (ERmax) after dabigatran alone and after dabigatran following enoxaparin administration
Time frame: Baseline and up to 48 hours after drug administration
18 secondary outcomes
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) of dabigatran
Time frame: Up to 48 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax) of dabigatran
Time frame: Up to 48 hours after drug administration
Terminal rate constant in plasma (λz) of dabigatran
Time frame: Up to 48 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2) of dabigatran
Time frame: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo) of dabigatran
Time frame: Up to 48 hours after drug administration
Apparent clearance of the analyte in plasma after extravascular administration (CL/F) of dabigatran
Time frame: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular administration (Vz/F) of dabigatran
Time frame: Up to 48 hours after drug administration
Anti-FIIa activity for Dabigatran etexilate
Time frame: Up to 48 hours after drug administration
Anti-FXa/anti-FIIa activity for Enoxaparin
Time frame: Up to 48 hours after drug administration
Activated partial thromboplastin time (aPTT) for Dabigatran etexilate
Time frame: Up to 48 hours after drug administration
Ecarin clotting time (ECT) for Dabigatran etexilate
Time frame: Up to 48 hours after drug administration
Thrombin time (TT) for Dabigatran etexilate
Time frame: Up to 48 hours after drug administration
Change in vital signs (blood pressure, pulse rate)
Time frame: up to day 61
Change in 12-lead electrocardiogram (ECG)
Time frame: up to day 61
Change in clinical laboratory tests
Time frame: up to day 61
Occurrence of adverse events
Time frame: Up to day 61
Assessment of global tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: Day 61
Assessment of local tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: day 3 of enoxaparin administration
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 Enoxaparin prefilled syringes and Dabigatran etexilate capsules 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 23 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?
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of dabigatran (time frame: Up to 48 hours after drug administration). The study lists 4 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.