HealthyPhase 1NCT02170844
Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin
A Phase 1 study testing BIBR 1048 MS in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single rising doses from 50 mg to 350 mg in healthy male subjects of Japanese and Caucasian origin. This was the first administration of this substance to subjects of Japanese 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Aug 2004
- 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 males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR, Respiratory Rate and tympanic body temperature), 12- lead ECG, 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
- BMI ≥18 and BMI ≤25 kg/m2 (Body Mass Index)
- 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 Good Clinical Practice (GCP) 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 if the male subject to use an adequate form of contraception as well as having their female partner(s) use another form of contraception (if the woman could become pregnant) from the time of the first dose administration until after follow up
- 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 - allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 25Show fewer
- 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 Antiinflammatory Drugs (NSAIDs) (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.
- Use of all other medication including over the counter (medicinal cream, vitamin, eye drop etc.) within 7 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)
- History of drug abuse
- Blood donation (more than 100 mL within three months prior to screening administration and any blood donation from screening to follow-up)
- Excessive physical activities (within one week prior to administration or during the trial and until follow-up)
- Any laboratory value outside the reference range that is 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/micro L
About this study
Official title: Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of 50, 150 and 350 mg BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin. Double-blind at Each Dose Level, Placebo-controlled, Randomised Study
To investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single rising doses from 50 mg to 350 mg in healthy male subjects of Japanese and Caucasian origin. This was the first administration of this substance to subjects of Japanese origin.
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS, Placebo of 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
Placebo of BIBR 1048 MSDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 MS (Japanese) | Experimental | Japanese subjects received an increasing dose (50 mg to 150 mg) of BIBR 1048 MS Receives: Drug: BIBR 1048 MS |
| BIBR 1048 MS Placebo (Japanese) | Placebo comparator | Japanese subjects will receive placebo of BIBR 1048 MS Receives: Drug: Placebo of BIBR 1048 MS |
| BIBR 1048 MS (Caucasian) | Experimental | Caucasian subjects received an increasing dose (50 mg to 150 mg) of BIBR 1048 MS Receives: Drug: BIBR 1048 MS |
| BIBR 1048 MS Placebo (Caucasian) | Placebo comparator | Japanese subjects will receive placebo of BIBR 1048 MS Receives: Drug: Placebo of BIBR 1048 MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood pressure (BP)
Measured: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in pulse rate (PR)
Measured: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in respiratory rate
Measured: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in tympanic body temperature
Measured: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in 12-Lead electrocardiogram (ECG)
Measured: At screening (day -14 to -3), at day -1, pre-dose, 2, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in haematology
Measured: At screening (day -14 to -3), at day -1 (pre-dose), 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in blood chemistry
Measured: At screening (day -14 to -3), at day -1 (pre-dose), 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in urinalysis
Measured: At screening (day -14 to -3), at day -1 (pre-dose), 4, 8, 12, 24, 36, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Occurence of adverse events
Measured: Up to visit 5 (day 10 - 14)
Secondary outcomes (16)
Cmax (maximum concentration of the analyte in plasma)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
tmax (time from dosing to maximum concentration)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable point)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
λz (terminal rate constant in plasma)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
(Pharmacokinetic parameters)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Measured: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-36 and 36-48 h after administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-36 and 36-48 h after administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-36 and 36-48 h after administration
Change from baseline for activated Partial Thromboplastin Time (aPTT)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Change from baseline for Ecarin clotting time (ECT)
(Pharmacodynamic parameters)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Change from baseline for thrombin time (TT)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Change from baseline for international normalised ratio (INR)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after 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 2004
- Primary completionAug 2004
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT02170844
- Sponsor's protocol ID
- 1160.28
- 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 Rising Oral Doses of 50, 150 and 350 mg BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin. Double-blind at Each Dose Level, Placebo-controlled, Randomised Study
- ClinicalTrials.gov ID
- NCT02170844
- Acronym / sponsor ID
- 1160.28
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2004 (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 and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single rising doses from 50 mg to 350 mg in healthy male subjects of Japanese and Caucasian origin. This was the first administration of this substance to subjects of Japanese origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 MS (Japanese) | Experimental | Drug: BIBR 1048 MSJapanese subjects received an increasing dose (50 mg to 150 mg) of BIBR 1048 MS |
| BIBR 1048 MS Placebo (Japanese) | Placebo comparator | Drug: Placebo of BIBR 1048 MSJapanese subjects will receive placebo of BIBR 1048 MS |
| BIBR 1048 MS (Caucasian) | Experimental | Drug: BIBR 1048 MSCaucasian subjects received an increasing dose (50 mg to 150 mg) of BIBR 1048 MS |
| BIBR 1048 MS Placebo (Caucasian) | Placebo comparator | Drug: Placebo of BIBR 1048 MSJapanese subjects will receive placebo of BIBR 1048 MS |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR, Respiratory Rate and tympanic body temperature), 12- lead ECG, clinical laboratory tests
- Age ≥20 and Age ≤45 years
- BMI ≥18 and BMI ≤25 kg/m2 (Body Mass Index)
- 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.
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 if the male subject to use an adequate form of contraception as well as having their female partner(s) use another form of contraception (if the woman could become pregnant) from the time of the first dose administration until after follow up
- 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 | Drug | BIBR 1048 MS (Caucasian), BIBR 1048 MS (Japanese) |
| Placebo of BIBR 1048 MS | Drug | BIBR 1048 MS Placebo (Caucasian), BIBR 1048 MS Placebo (Japanese) |
Primary outcome
Change from baseline in blood pressure (BP)
Time frame: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in pulse rate (PR)
Time frame: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in respiratory rate
Time frame: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in tympanic body temperature
Time frame: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in 12-Lead electrocardiogram (ECG)
Time frame: At screening (day -14 to -3), at day -1, pre-dose, 2, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in haematology
Time frame: At screening (day -14 to -3), at day -1 (pre-dose), 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in blood chemistry
Time frame: At screening (day -14 to -3), at day -1 (pre-dose), 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Change from baseline in urinalysis
Time frame: At screening (day -14 to -3), at day -1 (pre-dose), 4, 8, 12, 24, 36, 48 h after administration and on visit 5 (day 10 to day 14 after administration)
Occurence of adverse events
Time frame: Up to visit 5 (day 10 - 14)
16 secondary outcomes
Cmax (maximum concentration of the analyte in plasma)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
tmax (time from dosing to maximum concentration)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable point)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
λz (terminal rate constant in plasma)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-36 and 36-48 h after administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-36 and 36-48 h after administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-36 and 36-48 h after administration
Change from baseline for activated Partial Thromboplastin Time (aPTT)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Change from baseline for Ecarin clotting time (ECT)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Change from baseline for thrombin time (TT)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
Change from baseline for international normalised ratio (INR)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after 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 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 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 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. Some participants in this study may receive a placebo. 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 blood pressure (BP) (time frame: At screening (day -14 to -3), at day -1, pre-dose, 2, 8, 24, 48 h after administration and on visit 5 (day 10 to day 14 after administration)). The study lists 9 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.