HealthyPhase 1NCT02171468
Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male Subjects
A Phase 1 study testing Dabigatran high dose and Dabigatran low dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days) in healthy male subjects between Japanese and Caucasians Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dabigatran high dose and Dabigatran low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Jul 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese or Caucasian healthy male subjects according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead electrocardiogram, clinical laboratory tests
- No finding of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Caucasian subjects are from a well-defined Caucasian population, both parents of Caucasians, the subjects can understand the subject information for informed consent in English and the subjects have lived 8 or less than 8 years in Japan
- Age: ≥20 and ≤45 years
- Body mass index (BMI): ≥18.5 and ≤29.9 kg/m2
- Signed and dated written informed consent before admission to the trial site
Who cannot join
- Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
- Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders
- History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts
- Chronic or relevant acute infections
- History of
Show all 24Show fewer
- allergy/hypersensitivity (including drug allergy) which is deemed relevant to the safety assessment as judged by the investigator (excluding asymptomatic seasonal rhinitis/hay fever)
- any bleeding disorder including prolonged or habitual bleeding
- other hematologic diseases
- cerebral bleeding (e.g. after a car accident)
- concussions (head trauma resulting in injuring to brain) with or without loss of consciousness
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial
- Use of aspirin (including over-the-counter medications), antipletelet agents like ticlopidine or dipyridamole, chronic administration of nonsteroidal antiinflammatory drugs , coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 28 days prior to administration up to end-of-study examination
- Participation in another trial with an investigational drug within 3 months prior to administration up to end-of-study examination
- Smoker (>10 cigarettes/day or inability to refrain from smoking during the trial)
- Alcohol abuse (more than 60 g/day; confirmed by interview)
- Drug abuse (confirmed by interview)
- Blood donation (more than 100 mL from 3 months prior to screening and any blood donation from screening up to end-of-study examination)
- Excessive physical activities (within 7 days prior to the first drug administration up to end-of-study examination)
- Any laboratory value outside the reference range that is of clinical relevance
- Known hypersensitivity to the investigational drug or its excipients
- Subject who was judged ineligible by the investigator or the sub-investigator
- History of any familial bleeding disorder
- Thrombocytes <15 x 10**4 /microL
About this study
Official title: Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule (110 mg and 150 mg b.i.d., 7 Days) in Healthy Japanese and Caucasian Male Subjects (Open Label Study)
To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days) in healthy male subjects between Japanese and Caucasians
- Conditions
- Healthy
- Being tested
- 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.
Dabigatran high doseDrug
Dabigatran low doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran high dose | Experimental | Not described Receives: Drug: Dabigatran high dose |
| Dabigatran low dose | Experimental | Not described Receives: Drug: Dabigatran low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: up to 10 days
Changes in QT(c) intervals
Measured: up to 7 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Measured: up to 7 days
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to 7 days
Secondary outcomes (16)
Cmax (maximum measured concentration)
Measured: day 1
tmax (time from dosing to maximum measured concentration)
Measured: day 1
AUCτ,1 (area under the concentration-time curve over a uniform dosing interval τ after administration of single dose on Day 1)
Measured: day 1
tmax,ss (time from last dosing to maximum concentration at steady state)
Measured: up to 7 days
Cmin,ss (minimum concentration at steady state over a uniform dosing interval τ)
Measured: up to 7 days
λz,ss (terminal rate constant at steady state)
Measured: up to 7 days
t1/2,ss (terminal half-life at steady state)
Measured: up to 7 days
MRTpo,ss (mean residence time in the body at steady state after oral administration)
Measured: up to 7 days
CL/F,ss (apparent clearance in the plasma at steady state after extravascular multiple dose administration)
Measured: up to 7 days
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: up to 7 days
RA,Cmax,13 (accumulation ratio calculated as Cmax,ss/Cmax)
Measured: up to 7 days
RA,AUC,13 (accumulation ratio calculated as AUCτ,ss/AUCτ,1)
Measured: up to 7 days
area under the curve for activated partial thromboplastin time (aPTT)
Measured: 0 - 12 hours after adminstration on day 1 and day 7
area under the curve for ecarin clotting time (ECT)
Measured: 0 - 12 hours after adminstration on day 1 and day 7
comparison of trough concentrations
Measured: after doses 3, 5, 7, 9, 11 and 13
comparison of trough concentrations morning versus evening
Measured: after doses 9, 10, 11, 12, 13
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 startMay 2006
- Primary completionJul 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT02171468
- Sponsor's protocol ID
- 1160.61
- 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
- Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule (110 mg and 150 mg b.i.d., 7 Days) in Healthy Japanese and Caucasian Male Subjects (Open Label Study)
- ClinicalTrials.gov ID
- NCT02171468
- Acronym / sponsor ID
- 1160.61
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2006 (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 and compare pharmacokinetics, safety and pharmacodynamics of dabigatran etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days) in healthy male subjects between Japanese and Caucasians
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran high dose | Experimental | Drug: Dabigatran high dose |
| Dabigatran low dose | Experimental | Drug: Dabigatran low dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Japanese or Caucasian healthy male subjects according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead electrocardiogram, clinical laboratory tests
- Age: ≥20 and ≤45 years
- Body mass index (BMI): ≥18.5 and ≤29.9 kg/m2
- Signed and dated written informed consent before admission to the trial site
Key exclusion criteria (24 listed)
- Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
- Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders
- History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts
- Chronic or relevant acute infections
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 high dose | Drug | Dabigatran high dose |
| Dabigatran low dose | Drug | Dabigatran low dose |
Primary outcome
Occurrence of adverse events
Time frame: up to 10 days
Changes in QT(c) intervals
Time frame: up to 7 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time frame: up to 7 days
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 7 days
16 secondary outcomes
Cmax (maximum measured concentration)
Time frame: day 1
tmax (time from dosing to maximum measured concentration)
Time frame: day 1
AUCτ,1 (area under the concentration-time curve over a uniform dosing interval τ after administration of single dose on Day 1)
Time frame: day 1
tmax,ss (time from last dosing to maximum concentration at steady state)
Time frame: up to 7 days
Cmin,ss (minimum concentration at steady state over a uniform dosing interval τ)
Time frame: up to 7 days
λz,ss (terminal rate constant at steady state)
Time frame: up to 7 days
t1/2,ss (terminal half-life at steady state)
Time frame: up to 7 days
MRTpo,ss (mean residence time in the body at steady state after oral administration)
Time frame: up to 7 days
CL/F,ss (apparent clearance in the plasma at steady state after extravascular multiple dose administration)
Time frame: up to 7 days
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: up to 7 days
RA,Cmax,13 (accumulation ratio calculated as Cmax,ss/Cmax)
Time frame: up to 7 days
RA,AUC,13 (accumulation ratio calculated as AUCτ,ss/AUCτ,1)
Time frame: up to 7 days
area under the curve for activated partial thromboplastin time (aPTT)
Time frame: 0 - 12 hours after adminstration on day 1 and day 7
area under the curve for ecarin clotting time (ECT)
Time frame: 0 - 12 hours after adminstration on day 1 and day 7
comparison of trough concentrations
Time frame: after doses 3, 5, 7, 9, 11 and 13
comparison of trough concentrations morning versus evening
Time frame: after doses 9, 10, 11, 12, 13
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.
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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 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 8 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 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?
Occurrence of adverse events (time frame: up to 10 days). 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.