To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI 1744 CL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Number of patients with abnormal findings in physical examination
Time frame: Baseline, Day 10 after drug administration
Number of patients with clinically significant changes in vital signs
Time frame: Baseline and up to day 10 after drug administration
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters
Time frame: Baseline and up to day 10 after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline and up to day 10 after administration
Number of patients with adverse events
Time frame: Up to day 10
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 10 after drug administration
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Time frame: Up to 48 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 48 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: Up to 48 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: Up to 48 hours after drug administration
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λz (terminal rate constant in plasma)
Time frame: Up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 48 hours after drug administration
MRT (mean residence time of the analyte in the body after intravenous administration)
Time frame: Up to 48 hours after drug administration
CL (total clearance of the analyte in plasma after intravascular administration)
Time frame: Up to 48 hours after drug administration
V (apparent volume of distribution at different time points following an intravascular dose)
Time frame: Up to 48 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 96 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: Up to 96 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 96 hours after drug administration