To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters of coagulation, platelet activation and inflammation in a model of tissue factor triggered activation of the coagulation system; to examine the safety of BIBT 986 in this setting
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Change in activated partial thromboplastin time (aPTT)
Time frame: up to 48 hours after start of treatment
Change in international normalized ratio (INR)
Time frame: up to 48 hours after start of treatment
Change in thrombin time (TT)
Time frame: up to 48 hours after start of treatment
Change in ecarin clotting time (ECT)
Time frame: up to 48 hours after start of treatment
Change in prothrombin fragment (F1+2)
Time frame: up to 48 hours after start of treatment
Change in D-dimer
Time frame: up to 48 hours after start of treatment
Change in thrombin anti-thrombin complexes (TAT)
Time frame: up to 48 hours after start of treatment
Change in protein C activity
Time frame: up to 48 hours after start of treatment
Change in antithrombin
Time frame: up to 48 hours after start of treatment
Change in thrombomodulin
Time frame: up to 48 hours after start of treatment
Change in tissue factor messenger RNA (mRNA)
Time frame: up to 48 hours after start of treatment
Change in platelet count
Time frame: up to 48 hours after start of treatment
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Endotoxin derived from E. coli bacteria, used for activation of coagulation
Change in plasmin antiplasmin complexes (PAP)
Time frame: Pre-dose, up to day 14 after start of treatment
Change in soluble P-selectin
Time frame: up to 48 hours after start of treatment
Change in tumor necrosis factor alpha (TNF alpha)
Time frame: up to 48 hours after start of treatment
Change in interleukin-6 (IL-6)
Time frame: up to 48 hours after start of treatment
Change in primary haemostasis measured by closure times
Time frame: up to 48 hours after start of treatment
Number of subjects with clinically relevant changes in vital signs
blood pressure, pulse rate, body temperature
Time frame: up to 14 days after start of treatment
Number of subjects with clinically relevant changes in laboratory parameters
Time frame: up to 14 days after start of treatment
Number of subjects with adverse events
Time frame: up to 14 days after start of treatment
Number of subjects with clinically relevant changes in ECG
Time frame: up to 14 days after start of treatment
Change in thrombus precursor protein
Time frame: up to 48 hours after start of treatment
Change in soluble E-selectin
Time frame: up to 48 hours after start of treatment
Area under the plasma concentration-time curve (AUC)
Time frame: up to 48 hours after start of treatment
Maximum concentration in plasma at the end of the infusion (Cgh)
Time frame: up to 48 hours after start of treatment
Apparent terminal half-life of BIBT 986 in plasma (t1/2)
Time frame: up to 48 hours after start of treatment
Mean residence time of BIBT 986 in the body after intravenous bolus administration (MRT)
Time frame: up to 48 hours after start of treatment
Volume of distribution of BIBT 986 in plasma at steady state (Vss)
Time frame: up to 48 hours after start of treatment
Apparent volume of distribution of BIBT 986 during the terminal phase after intravenous infusion (Vz)
Time frame: up to 48 hours after start of treatment