Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
Time frame: up to 48 hours after start of infusion
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single dose administration)
Time frame: up to 48 hours after start of infusion
C29 (plasma concentration of BIBT 986 BS at the end of infusion)
Time frame: 29 minutes after start of infusion
t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
Time frame: up to 48 hours after start of infusion
CL (Total clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours after start of infusion
Vss (Apparent volume of distribution at steady state following intravascular administration)
Time frame: up to 48 hours after start of infusion
urinary excretion of BIBT 986 BS
Time frame: up to 48 hours after start of infusion
CLR (Renal clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours after start of infusion
MRT (Mean residence time of drug molecules in the body after intravascular administration)
Time frame: up to 48 hours after start of infusion
Change in activated partial thromboplastin time (aPTT)
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Time frame: up to 48 hours after start of infusion
Change in International Normalised Ratio (INR)
Time frame: up to 48 hours after start of infusion
Change in ecarin clotting time (ECT)
Time frame: up to 48 hours after start of infusion
Change in thrombin time (TT)
Time frame: up to 48 hours after start of infusion
Number of patients with clinically significant findings in vital signs
pulse rate, blood pressure
Time frame: up to 48 hours after start of infusion
Number of patients with clinically significant findings in electrocardiogram
Time frame: up to 48 hours after start of infusion
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 48 hours after start of infusion
Number of patients with adverse events
Time frame: up to 48 hours after start of infusion
Number of patients with histamine in blood
Time frame: up to 48 hours after start of infusion