To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
Number of patients with adverse events
Time frame: up to day 16
Number of patients with clinically significant findings in vital signs (blood pressure, heart rate)
Time frame: up to day 16
Number of patients with clinically significant findings ECG
Time frame: up to day 16
Number of patients with clinically significant findings laboratory tests
Time frame: up to day 16
Assessment of global tolerability by investigator on a 4-point scale
Time frame: within 9 to 16 days after drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 192 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 192 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 192 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 192 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 192 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 192 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 192 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 192 hours after drug administration
CL/F (total clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 192 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 192 hours after drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: up to 120 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 120 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 120 hours after drug administration
Change in Dipeptidyl peptidase IV (DDP-IV) activity
Time frame: up to 192 hours after drug administration