HealthyPhase 1NCT02171000
Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects
A Phase 1 study testing BIBR 1048 MS in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of multiple doses (150 mg b.i.d., 7 days) Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 1048 MS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to May 2005
- 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 35 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 and body temperature), 12-lead ECG, clinical laboratory tests
- 1.1 No finding of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥20 and Age ≤35 years
- Body Mass Index (BMI) ≥18 and BMI <25 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the trial in accordance with Japanese GCP (Ministry of Health, Labour and Welfare Ordinance No.28, March 27, 1997).
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subject was not able to use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
- Diseases of the central nervous system (such as epilepsy), 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 was 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 was shorter, of the respective drug prior to administration or during the trial
- Use of aspirin (including over-the-counter medications), antiplatelet agents like ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs, coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 14 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 was 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 104 /μL
About this study
Official title: Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule (150 mg b.i.d., 7 Days) in Healthy Japanese Male Subjects (Open Label Study)
To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of multiple doses (150 mg b.i.d., 7 days)
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 MSDrug
Also called dabigatran etexilate
150 mg capsules, b.i.d, 7 days
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 | Experimental | BIBR 1048 MS Receives: Drug: BIBR 1048 MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in physical examination
Measured: within 14 days prior to drug administration until up to 18 days post drug administration
Change from baseline in vital signs
Measured: within 14 days prior to drug administration until up to 18 days post drug administration
Change from baseline in 12-lead electrocardiogram (ECG)
Measured: within 14 days prior to drug administration until up to 18 days post drug administration
Change from baseline in clinical laboratory tests
Measured: within 14 days prior to drug administration until up to 18 days post drug administration
Number of participants with adverse events
Measured: within 14 days prior to drug administration until up to 18 days post drug administration
Secondary outcomes (22)
Changes in activated partial thromboplastin time (aPTT)
Measured: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Changes in ecarin clotting time (ECT)
Measured: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Changes in thrombin time (TT)
Measured: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Changes in prothrombin time expressed as international normalised ratio (INR)
Measured: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Measured: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the single dose on Day 1 (AUCτ,1)
Measured: Day 1 before, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after drug administration in the morning
Amount of analyte that is eliminated in urine from the time point t1 to time point t2 ( Aet1-t2 )
Measured: Day 1: 0-4, 4-8, 8-12 and 12-24 hours after the first drug administration, on Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2 )
Measured: Day 1: 0-4, 4-8, 8-12 and 12-24 hours after the first drug administration, on Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Measured: Day 1: 0-4, 4-8, 8-12 and 12-24 hours after the first drug administration, on Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Terminal rate constant in plasma at steady state (λz,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Mean residence time of the analyte in the body at steady state after po administration (MRTpo,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2 (Aet1-t2,ss)
Measured: Day 7 : 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Fraction of analyte eliminated in urine at steady state from time point t1 to time point t2 (fet1-t2,ss)
Measured: Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state (CLR,t1-t2,ss)
Measured: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final 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 startApr 2005
- Primary completionMay 2005
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT02171000
- Sponsor's protocol ID
- 1160.55
- 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
- Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule (150 mg b.i.d., 7 Days) in Healthy Japanese Male Subjects (Open Label Study)
- ClinicalTrials.gov ID
- NCT02171000
- Acronym / sponsor ID
- 1160.55
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- May 2005 (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 safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of multiple doses (150 mg b.i.d., 7 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 | Experimental | Drug: BIBR 1048 MSBIBR 1048 MS |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 and body temperature), 12-lead ECG, clinical laboratory tests
- Age ≥20 and Age ≤35 years
- Body Mass Index (BMI) ≥18 and BMI <25 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the trial in accordance with Japanese GCP (Ministry of Health, Labour and Welfare Ordinance No.28, March 27, 1997).
Key exclusion criteria (24 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subject was not able to use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
- Diseases of the central nervous system (such as epilepsy), 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 |
|---|---|---|
| BIBR 1048 MSAlso: dabigatran etexilate150 mg capsules, b.i.d, 7 days | Drug | BIBR 1048 |
Primary outcome
Change from baseline in physical examination
Time frame: within 14 days prior to drug administration until up to 18 days post drug administration
Change from baseline in vital signs
Time frame: within 14 days prior to drug administration until up to 18 days post drug administration
Change from baseline in 12-lead electrocardiogram (ECG)
Time frame: within 14 days prior to drug administration until up to 18 days post drug administration
Change from baseline in clinical laboratory tests
Time frame: within 14 days prior to drug administration until up to 18 days post drug administration
Number of participants with adverse events
Time frame: within 14 days prior to drug administration until up to 18 days post drug administration
22 secondary outcomes
Changes in activated partial thromboplastin time (aPTT)
Time frame: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Changes in ecarin clotting time (ECT)
Time frame: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Changes in thrombin time (TT)
Time frame: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Changes in prothrombin time expressed as international normalised ratio (INR)
Time frame: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Time frame: Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the single dose on Day 1 (AUCτ,1)
Time frame: Day 1 before, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after drug administration in the morning
Amount of analyte that is eliminated in urine from the time point t1 to time point t2 ( Aet1-t2 )
Time frame: Day 1: 0-4, 4-8, 8-12 and 12-24 hours after the first drug administration, on Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2 )
Time frame: Day 1: 0-4, 4-8, 8-12 and 12-24 hours after the first drug administration, on Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Time frame: Day 1: 0-4, 4-8, 8-12 and 12-24 hours after the first drug administration, on Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Terminal rate constant in plasma at steady state (λz,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Mean residence time of the analyte in the body at steady state after po administration (MRTpo,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final drug administration
Amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2 (Aet1-t2,ss)
Time frame: Day 7 : 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Fraction of analyte eliminated in urine at steady state from time point t1 to time point t2 (fet1-t2,ss)
Time frame: Day 7: 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours after the last drug administration
Renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state (CLR,t1-t2,ss)
Time frame: Day 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours after final 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 BIBR 1048 MS 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 7 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?
Change from baseline in physical examination (time frame: within 14 days prior to drug administration until up to 18 days post drug administration). The study lists 5 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.