Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood coagulation parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours post dose
CT (concentration of the analyte at the end of drug infusion)
Time frame: up to 48 hours post dose
Css (steady state concentration of the analyte in plasma following a constant rate infusion)
Time frame: up to 48 hours post dose
Tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 hours post dose
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 post dose
t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
Time frame: up to 48 hours post dose
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 post dose
λz (terminal rate constant of the analyte in plasma)
Time frame: up to 48 hours post dose
MRTinf (mean residence time of the analyte in the body after intravenous infusion)
Time frame: up to 48 hours post dose
CL (Total clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vss (Apparent volume of distribution at steady state following intravascular administration)
Time frame: up to 48 hours post dose
Vz (apparent volume of distribution during the terminal phase λz following intravascular administration)
Time frame: up to 48 hours post dose
Amount of parent drug eliminated in urine (Ae)
Time frame: up to 48 hours post dose
Change in activated partial thromboplastin time (aPTT)
Time frame: up to 48 hours post dose
Change in prothrombin time (PT)
Time frame: up to 48 hours post dose
Change in ecarin clotting time (ECT)
Time frame: up to 48 hours post dose
Change in thrombin time (TT)
Time frame: up to 48 hours post dose
Number of subjects with adverse events
Time frame: up to 4 days
Number of subjects with clinically significant changes in vital signs
Pulse rate, systolic \& diastolic blood pressure
Time frame: up to 4 days
Change in International Normalised Ratio (INR)
Time frame: up to 48 hours post dose
Fraction of administered drug excreted unchanged in urine (fe)
Time frame: up to 48 hours post dose
CLR (renal clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours post dose