- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170844
Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
- 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
Exclusion criteria specific for this study:
- History of any familial bleeding disorder
- Thrombocytes < 150000/micro L
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIBR 1048 MS (Japanese)
Japanese subjects received an increasing dose (50 mg to 150 mg) of BIBR 1048 MS
|
|
Placebo Comparator: BIBR 1048 MS Placebo (Japanese)
Japanese subjects will receive placebo of BIBR 1048 MS
|
|
Experimental: BIBR 1048 MS (Caucasian)
Caucasian subjects received an increasing dose (50 mg to 150 mg) of BIBR 1048 MS
|
|
Placebo Comparator: BIBR 1048 MS Placebo (Caucasian)
Japanese subjects will receive placebo of BIBR 1048 MS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
Up to visit 5 (day 10 - 14)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
(Pharmacokinetic parameters)
|
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
|
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
|
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
|
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
|
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
|
(Pharmacodynamic parameters)
|
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
|
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
|
pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after administration
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1160.28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on BIBR 1048 MS
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted