HealthyPhase 1NCT02170909
Safety, Pharmacokinetics and Pharmacodynamics of BIBR 1048 MS Capsule in Healthy Male Subjects of Japanese and Caucasian Origin
A Phase 1 study testing BIBR 1048 MS low dose, BIBR 1048 MS medium dose and BIBR 1048 MS high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and Caucasian origin. 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?
- BIBR 1048 MS low dose, BIBR 1048 MS medium dose and BIBR 1048 MS high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jun 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects of Japanese or Caucasian origin according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, respiratory rate and tympanic body temperature), 12- lead ECG (electrocardiogram), clinical laboratory tests
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥ 20 and Age ≤ 45 years
- Body mass index (BMI) ≥ 18 and ≤ 25 kg/m2
- Japanese subjects were from a well-defined Japanese population, both parents of Japanese origin and the subjects have Japanese passport and had lived ≤ 8 years outside Japan.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.
Who cannot join
- Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women, or an unwillingness of male subjects to use an adequate form of contraception as well as having their female partner(s) use another form of contraception (if the woman possibly become pregnant) from the time of the single dose on Day 1 until Day 22-26 (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 25Show fewer
- allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- any bleeding disorder including prolonged or habitual bleeding
- other hematologic disease
- 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 one month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial
- Use of acetylsalicylic acid (ASA)-containing over-the-counter medications, clopidogrel or ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs) (cyclooxygenase-2 (COX-2) inhibitors excluded), coumadin like anticoagulants, chronic use of corticosteroids, heparin and fibrinolytic agents within 14 days prior to administration or during the trial.
- Participation in another trial with an investigational drug within three months prior to administration or during the trial
- Smoker (> 10 cigarettes/day or > 3 cigars/day or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 21unit/week; one unit was approximately half a pint of beer, a small glass of wine or one measure of spirits)
- History of drug abuse
- Blood donation (more than 100 mL within three months prior to screening administration and any blood donation from screening to end-of-study examination)
- Excessive physical activities (within one week prior to administration or during the trial and until end-of-study examination)
- Any laboratory value outside the reference range that was of clinical relevance
- Inability to comply with dietary regimen of study centre
- Known hypersensitivity to the drug or its excipients
- History of any familial bleeding disorder
- Thrombocytes < 150000/μL
About this study
Official title: Safety, Pharmacokinetics and Pharmacodynamics After Single (150 mg, 220 mg and 300 mg) and Multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) Rising Oral Doses of BIBR 1048 MS/Capsules in Healthy Male Subjects of Japanese and Caucasian Origin. (Open Label Study)
Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and Caucasian origin.
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS low dose, BIBR 1048 MS medium dose, BIBR 1048 MS high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 MS low doseDrug
BIBR 1048 MS medium doseDrug
BIBR 1048 MS high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 MS low dose | Experimental | Not described Receives: Drug: BIBR 1048 MS low dose |
| BIBR 1048 MS medium dose | Experimental | Not described Receives: Drug: BIBR 1048 MS medium dose |
| BIBR 1048 MS high dose | Experimental | Not described Receives: Drug: BIBR 1048 MS high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vital signs
Measured: Baseline and up to day 26
Change in 12-lead electrocardiogram (ECG)
Measured: Baseline and up to day 26
Change in clinical laboratory tests
Measured: Baseline and up to day 26
Occurence of adverse events
Measured: Up to day 26
Secondary outcomes (36)
Area under the curve (AUC) from 0-24 hours for activated partial thromboplastin time (aPTT)
Measured: Day 1 and 12
AUC from 0-24 hours for ecarin clotting time (ECT)
Measured: Day 1 and 12
Change in thrombin time (TT)
Measured: Baseline and up to 72 hours after administration on day 1 and 12
Change in prothrombin time (PT) expressed as international normalised ratio (INR)
Measured: Baseline and up to 72 hours after administration on day 1 and 12
Maximum value of aPTT
Measured: Up to 72 hours after administration on day 1 and 12
Maximum value of ECT
Measured: Up to 72 hours after administration on day 1 and 12
Change in ECT
Measured: Baseline and up to 72 hours after administration on day 1 and 12
Change in aPTT
Measured: Baseline and up to 72 hours after administration on day 1 and 12
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to 72 hours after administration on day 1
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: Up to 72 hours after administration on day 1
AUCτ,1 (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)
Measured: Up to 72 hours after administration on day 1
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)
Measured: Up to 72 hours after administration on day 1
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 72 hours after administration on day 1
λz (terminal rate constant in plasma)
Measured: Up to 72 hours after administration on day 1
t1/2 (terminal half-life of the analyte in plasma)
Measured: Up to 72 hours after administration on day 1
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: Up to 72 hours after administration on day 1
CL/F (apparent clearance of the analyte in plasma following extravascular administration)
Measured: Up to 72 hours after administration on day 1
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
Measured: Up to 72 hours after administration on day 1
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Measured: Up to 72 hours after administration on day 1
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: Up to 72 hours after administration on day 1
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: Up to 72 hours after administration on day 1
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Up to 72 hours after the last dose on day 12
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Measured: Up to 72 hours after the last dose on day 12
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Up to 72 hours after the last dose on day 12
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 72 hours after the last dose on day 12
λz,ss (terminal rate constant in plasma at steady state)
Measured: Up to 72 hours after the last dose on day 12
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: Up to 72 hours after the last dose on day 12
MRTpo,ss (mean residence time of the analyte in the body at steady state after po administration)
Measured: Up to 72 hours after the last dose on day 12
CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration)
Measured: Up to 72 hours after the last dose on day 12
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: Up to 72 hours after the last dose on day 12
Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2)
Measured: Up to 72 hours after the last dose on day 12
fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2)
Measured: Up to 72 hours after the last dose on day 12
CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state)
Measured: Up to 72 hours after the last dose on day 12
Accumulation ratio RA,Cmax,7 based on Cmax
Measured: Day 6 to day 15
Accumulation ratio RA,AUC,7 based on AUCτ (only for 150 mg and 220 mg q.d. groups)
Measured: Day 6 to day 15
Linearity index (LI) based on AUC (only for 150 mg and 220 mg q.d. groups)
Measured: Day 6 to day 15
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 startDec 2004
- Primary completionJun 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT02170909
- Sponsor's protocol ID
- 1160.29
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacokinetics and Pharmacodynamics After Single (150 mg, 220 mg and 300 mg) and Multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) Rising Oral Doses of BIBR 1048 MS/Capsules in Healthy Male Subjects of Japanese and Caucasian Origin. (Open Label Study)
- ClinicalTrials.gov ID
- NCT02170909
- Acronym / sponsor ID
- 1160.29
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jun 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.
Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and Caucasian origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 MS low dose | Experimental | Drug: BIBR 1048 MS low dose |
| BIBR 1048 MS medium dose | Experimental | Drug: BIBR 1048 MS medium dose |
| BIBR 1048 MS high dose | Experimental | Drug: BIBR 1048 MS high dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subjects of Japanese or Caucasian origin according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, respiratory rate and tympanic body temperature), 12- lead ECG (electrocardiogram), clinical laboratory tests
- Age ≥ 20 and Age ≤ 45 years
- Body mass index (BMI) ≥ 18 and ≤ 25 kg/m2
- Japanese subjects were from a well-defined Japanese population, both parents of Japanese origin and the subjects have Japanese passport and had lived ≤ 8 years outside Japan.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.
Key exclusion criteria (25 listed)
- Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women, or an unwillingness of male subjects to use an adequate form of contraception as well as having their female partner(s) use another form of contraception (if the woman possibly become pregnant) from the time of the single dose on Day 1 until Day 22-26 (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 |
|---|---|---|
| BIBR 1048 MS low dose | Drug | BIBR 1048 MS low dose |
| BIBR 1048 MS medium dose | Drug | BIBR 1048 MS medium dose |
| BIBR 1048 MS high dose | Drug | BIBR 1048 MS high dose |
Primary outcome
Change in vital signs
Time frame: Baseline and up to day 26
Change in 12-lead electrocardiogram (ECG)
Time frame: Baseline and up to day 26
Change in clinical laboratory tests
Time frame: Baseline and up to day 26
Occurence of adverse events
Time frame: Up to day 26
36 secondary outcomes
Area under the curve (AUC) from 0-24 hours for activated partial thromboplastin time (aPTT)
Time frame: Day 1 and 12
AUC from 0-24 hours for ecarin clotting time (ECT)
Time frame: Day 1 and 12
Change in thrombin time (TT)
Time frame: Baseline and up to 72 hours after administration on day 1 and 12
Change in prothrombin time (PT) expressed as international normalised ratio (INR)
Time frame: Baseline and up to 72 hours after administration on day 1 and 12
Maximum value of aPTT
Time frame: Up to 72 hours after administration on day 1 and 12
Maximum value of ECT
Time frame: Up to 72 hours after administration on day 1 and 12
Change in ECT
Time frame: Baseline and up to 72 hours after administration on day 1 and 12
Change in aPTT
Time frame: Baseline and up to 72 hours after administration on day 1 and 12
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 72 hours after administration on day 1
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: Up to 72 hours after administration on day 1
AUCτ,1 (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)
Time frame: Up to 72 hours after administration on day 1
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)
Time frame: Up to 72 hours after administration on day 1
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 72 hours after administration on day 1
λz (terminal rate constant in plasma)
Time frame: Up to 72 hours after administration on day 1
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 72 hours after administration on day 1
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: Up to 72 hours after administration on day 1
CL/F (apparent clearance of the analyte in plasma following extravascular administration)
Time frame: Up to 72 hours after administration on day 1
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
Time frame: Up to 72 hours after administration on day 1
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: Up to 72 hours after administration on day 1
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: Up to 72 hours after administration on day 1
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: Up to 72 hours after administration on day 1
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Up to 72 hours after the last dose on day 12
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Time frame: Up to 72 hours after the last dose on day 12
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Up to 72 hours after the last dose on day 12
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 72 hours after the last dose on day 12
λz,ss (terminal rate constant in plasma at steady state)
Time frame: Up to 72 hours after the last dose on day 12
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: Up to 72 hours after the last dose on day 12
MRTpo,ss (mean residence time of the analyte in the body at steady state after po administration)
Time frame: Up to 72 hours after the last dose on day 12
CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration)
Time frame: Up to 72 hours after the last dose on day 12
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: Up to 72 hours after the last dose on day 12
Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2)
Time frame: Up to 72 hours after the last dose on day 12
fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2)
Time frame: Up to 72 hours after the last dose on day 12
CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state)
Time frame: Up to 72 hours after the last dose on day 12
Accumulation ratio RA,Cmax,7 based on Cmax
Time frame: Day 6 to day 15
Accumulation ratio RA,AUC,7 based on AUCτ (only for 150 mg and 220 mg q.d. groups)
Time frame: Day 6 to day 15
Linearity index (LI) based on AUC (only for 150 mg and 220 mg q.d. groups)
Time frame: Day 6 to day 15
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 31 Aug 2018.
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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 low dose, BIBR 1048 MS medium dose and BIBR 1048 MS high 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 7 inclusion and 25 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 31 Aug 2018. 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 in vital signs (time frame: Baseline and up to day 26). 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 31 Aug 2018.