Healthy
Conditions
Brief summary
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.
Interventions
DRUGBIBR 1048 MS low
DRUGBIBR 1048 MS medium 1
DRUGBIBR 1048 MS medium 2
DRUGBIBR 1048 MS high
DRUGBIBR 1048 MS placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects as determined by results of screening * Signed written informed consent in accordance with GCP and local legislation * Age ≥ 18 and ≤ 45 years * Broca ≥ -20% and ≤ +20%
Exclusion criteria
* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders * History of orthostatic hypotension, fainting spells and blackouts * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders * 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) * commotio cerebri * Intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration * Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial * Participation in another trial with an investigational drug within 2 months prior to administration or during trial * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation within 1 month prior to administration or during the trial * Excessive physical activities within 5 days prior to administration or during the trial * Any laboratory value outside the clinically accepted reference range * History of any familial bleeding disorder * Thrombocytes \< 150000/µl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in aPTT (activated partial thromboplastin time) | up to day 10 |
| Change in PT (prothrombin time) | up to day 10 |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-∞ (area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW | up to day 10 |
| Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW | Day 7 |
| Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW | Day 7 |
| Cavg (average plasma concentration at steady state) of BIBR 953 ZW | up to day 10 |
| PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW | up to day 10 |
| Cmax (maximum measured concentration) of BIBR 953 ZW | up to day 10 |
| t1/2 (terminal half-life) of BIBR 953 ZW | up to day 10 |
| AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW | up to day 10 |
| MRTss (mean residence time at steady state) of BIBR 953 ZW | up to day 10 |
| CLtot/F (total apparent clearance) of BIBR 953 ZW | up to day 10 |
| Vz/F (apparent volume of distribution) of BIBR 953 ZW | up to day 10 |
| tmax,ss (time to reach Cmax) of BIBR 953 ZW | up to day 10 |
| tmax (time from dosing to the maximum concentration) of BIBR 953 ZW | up to day 10 |
Outcome results
None listed