First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of BI 11634 on coagulation parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Number of subjects with adverse events
Time frame: up to 10 days after drug administration
Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)
Time frame: up to 10 days after drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 10 days after drug administration
Number of subjects with clinically significant findings laboratory tests
Time frame: up to 10 days after drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 10 days after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 72 hours after drug administration
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point)
Time frame: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 48 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 48 hours after drug administration
Activated partial thromboplastin time (aPTT) ratios between groups
Time frame: up to 72 hours after drug administration
Maximum aPTT prolongation
compared between groups
Time frame: up to 72 hours after drug administration
Maximum international normalized ratio (INR)
compared between groups
Time frame: up to 72 hours after drug administration
% inhibition of endogenous Factor Xa
by Russel's Viper Venom test (RVV)
Time frame: up to 72 hours after drug administration
Percent inhibition of thrombin generation by BI 11634
Time frame: up to 24 hours after drug administration
Percent peak inhibition of thrombin generation
Time frame: up to 24 hours after drug administration
Time to maximum inhibition of thrombin generation BI 11634
Time frame: up to 24 hours after drug administration
Percent prolongation of lag time
Time frame: up to 24 hours after drug administration
Area under the inhibition of the endogenous thrombin generation-time curve
Time frame: up to 24 hours after drug administration
Maximum prolongation of blood coagulation time
by HepTest® (Haemachem Inc.) and COAMATIC® Heparin test (Chromogenix)
Time frame: up to 72 hours after drug administration