To assess the influence of different degrees of renal impairment on safety, tolerability, pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose infusion over 30 minutes in comparison to a normal renal function
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 48 hours after drug administration
Time to reach the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 48 hours after drug administration
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: Up to 48 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
Time frame: Up to 48 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)
Time frame: Up to 48 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after intravenous infusion (MRTinf)
Time frame: Up to 48 hours after drug administration
Total clearance of the analyte from plasma following intravascular administration (CL)
Time frame: Up to 48 hours after drug administration
Apparent volume of distribution at steady state following an intravascular dose (Vss)
Time frame: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)
Time frame: Up to 48 hours after drug administration
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Amount of drug excreted in the urine (Ae)
Time frame: Up to 48 hours after drug administration
Change in activated partial thromboplastin time (aPTT)
Time frame: Up to 48 hours after drug administration
Change in ecarin clotting time (ECT)
Time frame: Up to 48 hours after drug administration
Change in International Normalized Ratio (INR)
Time frame: Up to 48 hours after drug administration
Change in thrombin time (TT)
Time frame: Up to 48 hours after drug administration
Plasma concentration of the analyte at the end of the intravenous infusion (CT)
Time frame: 29 minutes after drug administration
Number of participants with clinically significant changes in vital signs
Blood pressure and pulse rate
Time frame: Up to 3 days after drug administration
Number of participants with clinically significant changes in ECG (electrocardiogram)
Time frame: Up to 3 days after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 3 days after drug administration
Number of participants with adverse events
Time frame: Up to 3 days after drug administration
Change in prothrombin time (PT)
Time frame: Up to 48 hours after drug administration
partial area under the concentration time curve (from time 0 to last sampling time preceding hemodialysis in any of the patients) (AUCt1-t2)
Time frame: Up to 48 hours after drug administration
fraction of administered drug excreted unchanged in urine over the respective time interval (fe)
Time frame: Up to 48 hours after drug administration
Renal clearance of the analyte from plasma following intravascular administration (CLR)
Time frame: Up to 48 hours after drug administration