HealthyPhase 1NCT02171052
Relative Bioavailability of Dabigatran and Digoxin in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran etexilate and Digoxin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the bioavailability of dabigatran with and without concomitant administration of digoxin and the bioavailability of digoxin with and without concomitant administration of dabigatran etexilate 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?
- Dabigatran etexilate and Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Aug 2006
- 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 males and females according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 and ≤65 years
- BMI ≥18.5 and BMI ≤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
- 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
- Puls below 50 bpm at screening
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 24Show fewer
- 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
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Alcohol abuse (more than 60 g/day)
- 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 or during the trial)
- 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
- Females of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile or are sexually active and not using an acceptable form of contraception as either the oral contraceptives since at least two months and the double barrier method, i.e. intrauterine device with spermicide and condom for the male partner
- Male subjects must agree to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the post study medical. 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 month)
- Planned surgeries within four weeks following the end-of study examination
- Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, cumarin etc.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Vulnerable subjects (e.g. persons kept in detention).
About this study
Official title: Relative Bioavailability of Dabigatran and Digoxin After 150 mg BID Dabigatran Etexilate and Digoxin at 0.25 mg QD Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple-dose, Three-way Crossover Study)
To investigate the bioavailability of dabigatran with and without concomitant administration of digoxin and the bioavailability of digoxin with and without concomitant administration of dabigatran etexilate
- Conditions
- Healthy
- Being tested
- Dabigatran etexilate, Digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilateDrug
DigoxinDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate plus digoxin | Experimental | Not described Receives: Drug: Dabigatran etexilate; Drug: Digoxin |
| Dabigatran etexilate | Active comparator | Not described Receives: Drug: Dabigatran etexilate |
| Digoxin | Active comparator | Not described Receives: Drug: Digoxin |
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 at steady state over a uniform dosing interval τ (AUCτ,ss)
Measured: Up to 72 hours after drug administration on day 4
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
Measured: 2 hours before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration on day 4
Secondary outcomes (22)
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 (AUC0-tz,ss)
Measured: Up to 72 hours after drug administration on day 4
Time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state (tz,ss)
Measured: Up to 72 hours after drug administration on day 4
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Measured: Up to 72 hours after drug administration on day 4
Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/Fss)
Measured: Up to 72 hours after drug administration on day 4
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Measured: Up to 24 hours after drug administration on day 4
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: Up to 72 hours after drug administration on day 4
Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ ( tmin,ss)
Measured: Up to 72 hours after drug administration on day 4
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Measured: 2 hours before drug administration on day 4
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTp.o.,ss)
Measured: Up to 72 hours after drug administration on day 4
Fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ (feτ,ss)
Measured: Up to 24 hours after drug administration on day 4
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Measured: Day 76
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration (Vz/Fss)
Measured: Up to day 7
Amount of analyte that was eliminated in urine at steady state over an uniform dosing interval τ (Aeτ,ss)
Measured: Up to 24 hours after drug administration on day 4
Area under the effect ratio curve (AUERτ,ss) for activated prothrombin time (aPTT) and ecarin clotting time (ECT)
Measured: Up to 72 hours after drug administration on day 4
Prolongation at trough (ERpre,ss) for aPTT
Measured: Up to 72 hours after drug administration on day 4
Change from baseline in physical examination
Measured: Baseline, day 76
Change from baseline in vital signs (blood pressure, pulse rate)
Measured: Baseline, day 76
Change from baseline in 12-lead electrocardiogram
Measured: Baseline, day 76
Change from baseline in clinical laboratory tests
Measured: Baseline, day 76
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to day 76
Maximum effect ratio at steady state (ERmax,ss) for aPTT and ECT
Measured: Up to 72 hours after drug administration on day 4
Prolongation at trough (ERpre,ss) for ECT
Measured: Up to 72 hours after drug administration on day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2006
- Primary completionAug 2006
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
- 24 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
- NCT02171052
- Sponsor's protocol ID
- 1160.59
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Dabigatran and Digoxin After 150 mg BID Dabigatran Etexilate and Digoxin at 0.25 mg QD Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple-dose, Three-way Crossover Study)
- ClinicalTrials.gov ID
- NCT02171052
- Acronym / sponsor ID
- 1160.59
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2006 (actual)
- First posted
- 23 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 bioavailability of dabigatran with and without concomitant administration of digoxin and the bioavailability of digoxin with and without concomitant administration of dabigatran etexilate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate plus digoxin | Experimental | Drug: Dabigatran etexilate, Drug: Digoxin |
| Dabigatran etexilate | Active comparator | Drug: Dabigatran etexilate |
| Digoxin | Active comparator | Drug: Digoxin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males and females according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 and ≤65 years
- BMI ≥18.5 and BMI ≤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 (24 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
- Puls below 50 bpm at screening
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| Dabigatran etexilate | Drug | Dabigatran etexilate, Dabigatran etexilate plus digoxin |
| Digoxin | Drug | Dabigatran etexilate plus digoxin, Digoxin |
Primary outcome
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: Up to 72 hours after drug administration on day 4
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
Time frame: 2 hours before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration on day 4
22 secondary outcomes
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 (AUC0-tz,ss)
Time frame: Up to 72 hours after drug administration on day 4
Time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state (tz,ss)
Time frame: Up to 72 hours after drug administration on day 4
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: Up to 72 hours after drug administration on day 4
Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/Fss)
Time frame: Up to 72 hours after drug administration on day 4
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Time frame: Up to 24 hours after drug administration on day 4
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 72 hours after drug administration on day 4
Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ ( tmin,ss)
Time frame: Up to 72 hours after drug administration on day 4
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: 2 hours before drug administration on day 4
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTp.o.,ss)
Time frame: Up to 72 hours after drug administration on day 4
Fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ (feτ,ss)
Time frame: Up to 24 hours after drug administration on day 4
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: Day 76
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration (Vz/Fss)
Time frame: Up to day 7
Amount of analyte that was eliminated in urine at steady state over an uniform dosing interval τ (Aeτ,ss)
Time frame: Up to 24 hours after drug administration on day 4
Area under the effect ratio curve (AUERτ,ss) for activated prothrombin time (aPTT) and ecarin clotting time (ECT)
Time frame: Up to 72 hours after drug administration on day 4
Prolongation at trough (ERpre,ss) for aPTT
Time frame: Up to 72 hours after drug administration on day 4
Change from baseline in physical examination
Time frame: Baseline, day 76
Change from baseline in vital signs (blood pressure, pulse rate)
Time frame: Baseline, day 76
Change from baseline in 12-lead electrocardiogram
Time frame: Baseline, day 76
Change from baseline in clinical laboratory tests
Time frame: Baseline, day 76
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to day 76
Maximum effect ratio at steady state (ERmax,ss) for aPTT and ECT
Time frame: Up to 72 hours after drug administration on day 4
Prolongation at trough (ERpre,ss) for ECT
Time frame: Up to 72 hours after drug administration on day 4
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 23 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 Dabigatran etexilate and Digoxin 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 5 inclusion and 24 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 23 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 at steady state over a uniform dosing interval τ (AUCτ,ss) (time frame: Up to 72 hours after drug administration on day 4). 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 23 Jun 2014.