Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on coagulation parameters.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBT 1011 BS | Experimental |
| |
| BIBT 1011 BS placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single rising doses of BIBT 1011 BS | Drug |
| ||
| BIBT 1011 BS placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of activated partial thromboplastin time (aPTT) | Pre-dose, up to 48 hours after start of treatment | |
| Determination of international normalized ration (INR) | Pre-dose, up to 48 hours after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of thrombin time (TT) | Pre-dose, up to 48 hours after start of treatment | |
| Determination of ecarin clotting time (ECT) | Pre-dose, up to 48 hours after start of treatment | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any finding 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, immunological, hormonal disorders
History of orthostatic hypotension, fainting spells or blackouts
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Chronic or relevant acute infections
History of
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 the 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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Assessment of plasma concentration time profiles of BIBT 986 BS |
| Pre-dose, up to 48 hours after start of treatment |
| Maximum concentration of BIBT 986 BS in plasma (Cmax) | Pre-dose, up to 48 hours after start of treatment |
| Area under the concentration time curve for BIBT 986 BS (AUC) | Pre-dose, up to 48 hours after start of treatment |
| Time from dosing to when the plasma concentration reaches Cmax after a single extravascular dose (tmax) | Pre-dose, up to 48 hours after start of treatment |
| Total mean time of residence of BIBT 986 BS- molecules in the body (MRTtot) | Pre-dose, up to 48 hours after start of treatment |
| Apparent volume of distribution of the analytes during the terminal phase (Vz/f) | Pre-dose, up to 48 hours after start of treatment |
| Terminal elimination half life of BIBT 986 BS in plasma (t1/2) | Pre-dose, up to 48 hours after start of treatment |
| Amount excreted over the 24 hour sampling period (Ae0-24) | Pre-dose, up to 24 hours after start of treatment |
| Total clearance after oral administration (CLtot/F) | Pre-dose, up to 48 hours after start of treatment |
| Number of patients with adverse events | Up to 17 days |
| Assessment of BIBT 986 BS plasma concentration- aPTT relationship | Pre-dose, up to 48 hours after start of treatment |