Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of BI 10773 to healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Number of patients with adverse events
Time frame: up to 33 days
Number of patients with clinically significant changes in vital signs
Time frame: up to 12 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to day 4
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 12 days
Number of patients with abnormal findings in physical examination
Time frame: up to 12 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 12 days
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 72 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 72 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 72 hours after drug administration
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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)
Time frame: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
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 po administration)
Time frame: up to 72 hours after drug administration
CL/F (total clearance of the analyte in the 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
Ae t1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: up to 72 hours after drug administration
fe t1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 72 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 72 hours after drug administration