Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of BI 60732
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: up to day 21 after start of treatment
Number of patients with clinically relevant changes in 12-lead ECG
Time frame: up to day 21 after start of treatment
Number of patients with clinically relevant changes in laboratory parameters
Time frame: up to day 21 after start of treatment
Number of patients with clinically relevant changes in coagulation parameters
Parameters: * Activated partial thromboplastin time (aPTT) * Prothrombin time (PT) * HepTest®
Time frame: up to 72 hours after start of treatment
Number of patients with adverse events
Time frame: up to 6 weeks
Global assessment of tolerability by investigator on a 4-point scale
Time frame: up to 21 days after start of treatment
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 264 hours after start of treatment
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Time frame: up to 264 hours after start of treatment
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to 264 hours after start of treatment
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Terminal rate constant of the analyte in plasma (λz)
Time frame: up to 264 hours after start of treatment
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 264 hours after start of treatment
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: up to 264 hours after start of treatment
Apparent clearance of the analyte in plasma after extravascular administration (CL/F)
Time frame: up to 264 hours after start of treatment
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Time frame: up to 264 hours after start of treatment
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Time frame: up to 264 hours after start of treatment
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Time frame: Pre-dose, up to 264 hours after start of treatment
Changes in activated partial thromboplastin time (aPTT)
Time frame: Pre-dose, up to 72 hours after start of treatment
Changes in prothrombin time (PT)
Time frame: Pre-dose, up to 72 hours after start of treatment
Prolongation of coagulation time by Heptest®
Time frame: up to 72 hours after start of treatment
Inhibition of FXa activity
Russel's Viper Venom (RVV)
Time frame: Pre-dose up to 168 hours after start of treatment
Percentage inhibition of endogenous thrombin generation
Time frame: up to 24 hours after start of treatment
Percentage peak inhibition of thrombin generation
Time frame: up to 24 hours after start of treatment
Relative prolongation of time to maximum inhibition of thrombin generation
Time frame: up to 24 hours after start of treatment
Relative prolongation of lag time of thrombin generation
Time frame: up to 24 hours after start of treatment
Maximum effect (Emax)
Time frame: up to 168 hours after start of treatment
Time to maximum effect (tmax)
Time frame: up to 168 hours after start of treatment
Area under the effect curve (AUEC)
Time frame: up to 168 hours after start of treatment