Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for intravenous (i.v.) infusion
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
23
Number of patients with clinically significant findings in vital signs
Time frame: up to 16 days
Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)
Time frame: up to 16 days
Number of patients with clinically significant laboratory findings
Time frame: up to 16 days
Number of patients with adverse events
Time frame: up to 37 days
Assessment of global tolerability by investigator on a 4-point scale
Time frame: within 14 days after last trial procedure
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 24 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 24 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 24 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
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Time frame: up to 24 hours after drug administration
AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 hours after drug application)
Time frame: up to 2 hours after drug administration
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time point t1 to time point t2)
Time frame: up to 24 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 24 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 24 hours after drug administration
MRTinf (mean residence time of the analyte in the body after intravenous administration)
Time frame: up to 24 hours after drug administration
CL (total clearance of the analyte in plasma after intravascular administration)
Time frame: up to 24 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)
Time frame: up to 24 hours after drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)
Time frame: up to 24 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 24 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 24 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 24 hours after drug administration