HealthyPhase 1NCT02170675
Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran etexilate and Ketoconazole in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole affects plasma exposure of dabigatran. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dabigatran etexilate and Ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- 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 ≥21 and ≤50 years
- BMI range ≥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 finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial, and intake of drugs which might reasonably influence the results of the trial within four weeks prior to administration or during the trial (e.g. P-gp inducers)
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- 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 was of clinical relevance
- Inability to comply with dietary regimen of trial site
- Intake of medication, which influences the blood clotting, such as acetylsalicylic acid and oral vitamin K antagonists
- For female subjects:
- Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
- No adequate contraception during the study and until 1 month of study completion, i.e.
- implants, injectables, combined oral contraceptives, IUD [intrauterine device], sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl.
- hysterectomy). Females, who were not surgically sterile were asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
- Lactation period
About this study
Official title: Relative Bioavailability of Single Doses of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Ketoconazole (Tablet) or in Combination With 400 mg q.d. Ketoconazole (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
To investigate whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole affects plasma exposure of dabigatran.
- Conditions
- Healthy
- Being tested
- Dabigatran etexilate, Ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilateDrug
KetoconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate + Ketoconazole | Experimental | Period 1 - Dabigatran etexilate
Period 2 - Dabigatran etexilate and single dose of 400 mg Ketoconazole on Day 8 and 9
Period 3 - Dabigatran etexilate and multiple doses of 400 mg Ketoconazole on Day 10 to 16 Receives: Drug: Dabigatran etexilate; Drug: Ketoconazole |
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 for total dabigatran
Measured: up to Day 16
Maximum measured concentration of the analyte in plasma for total dabigatran
Measured: up to Day 16
Secondary outcomes (18)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for free dabigatran
Measured: up to Day 16
Maximum measured concentration of the analyte in plasma for free dabigatran
Measured: up to Day 16
Maximum measured concentration of the analyte in plasma for dabigatran and BIBR 1087 SE, BIBR 951 BS
Measured: up to Day 16
Time from dosing to the maximum concentration of the analyte in plasma for dabigatran and BIBR 1087 SE, BIBR 951 BS
Measured: up to Day 16
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Area under the concentration-time curve of the analyte in plasma over the time interval from timepoints t1 to t2 for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Time from dosing to the maximum concentration of the analyte in plasma for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Terminal rate constant of the analyte in plasma for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Terminal half-life of the analyte in plasma for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Mean residence time of the analyte in the body after oral administration for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Apparent clearance of the analyte in the plasma after extravascular administration for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Apparent volume of distribution during the terminal phase λz following an extravascular dose for dabigatran
Dabigatran after each single dose (free and total after conjugate cleavage)
Measured: up to Day 16
Changes from baseline in Vital signs (blood pressure [BP], pulse rate)
Measured: up to 14 days after last drug administration
Changes from baseline in 12-lead ECG
Measured: up to 14 days after last drug administration
Changes from baseline in Clinical laboratory tests (haematology, clinical chemistry, and urinalysis)
Measured: up to 14 days after last drug administration
Number of patients with adverse events
Measured: up to 14 days after last drug administration
Assessment of tolerability by the investigator
Measured: up to 14 days after last drug administration
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 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
- Non-randomised
- Intervention model
- Single group
- 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
- NCT02170675
- Sponsor's protocol ID
- 1160.101
- 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 Single Doses of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Ketoconazole (Tablet) or in Combination With 400 mg q.d. Ketoconazole (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
- ClinicalTrials.gov ID
- NCT02170675
- Acronym / sponsor ID
- 1160.101
- 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 2009
- Primary completion
- Jul 2009 (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 whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole affects plasma exposure of dabigatran.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate + Ketoconazole | Experimental | Drug: Dabigatran etexilate, Drug: KetoconazolePeriod 1 - Dabigatran etexilate Period 2 - Dabigatran etexilate and single dose of 400 mg Ketoconazole on Day 8 and 9 Period 3 - Dabigatran etexilate and multiple doses of 400 mg Ketoconazole on Day 10 to 16 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 ≥21 and ≤50 years
- BMI range ≥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 (24 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- 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 + Ketoconazole |
| Ketoconazole | Drug | Dabigatran etexilate + Ketoconazole |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for total dabigatran
Time frame: up to Day 16
Maximum measured concentration of the analyte in plasma for total dabigatran
Time frame: up to Day 16
18 secondary outcomes
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for free dabigatran
Time frame: up to Day 16
Maximum measured concentration of the analyte in plasma for free dabigatran
Time frame: up to Day 16
Maximum measured concentration of the analyte in plasma for dabigatran and BIBR 1087 SE, BIBR 951 BS
Time frame: up to Day 16
Time from dosing to the maximum concentration of the analyte in plasma for dabigatran and BIBR 1087 SE, BIBR 951 BS
Time frame: up to Day 16
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for dabigatran
Time frame: up to Day 16
Area under the concentration-time curve of the analyte in plasma over the time interval from timepoints t1 to t2 for dabigatran
Time frame: up to Day 16
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h for dabigatran
Time frame: up to Day 16
Time from dosing to the maximum concentration of the analyte in plasma for dabigatran
Time frame: up to Day 16
Terminal rate constant of the analyte in plasma for dabigatran
Time frame: up to Day 16
Terminal half-life of the analyte in plasma for dabigatran
Time frame: up to Day 16
Mean residence time of the analyte in the body after oral administration for dabigatran
Time frame: up to Day 16
Apparent clearance of the analyte in the plasma after extravascular administration for dabigatran
Time frame: up to Day 16
Apparent volume of distribution during the terminal phase λz following an extravascular dose for dabigatran
Time frame: up to Day 16
Changes from baseline in Vital signs (blood pressure [BP], pulse rate)
Time frame: up to 14 days after last drug administration
Changes from baseline in 12-lead ECG
Time frame: up to 14 days after last drug administration
Changes from baseline in Clinical laboratory tests (haematology, clinical chemistry, and urinalysis)
Time frame: up to 14 days after last drug administration
Number of patients with adverse events
Time frame: up to 14 days after last drug administration
Assessment of tolerability by the investigator
Time frame: up to 14 days after last drug 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 23 Jun 2014.
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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 Ketoconazole 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 over the time interval from 0 extrapolated to infinity for total dabigatran (time frame: up to Day 16). 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.