The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Number of subjects with abnormal findings in physical examination
Time frame: up to 48 hours following drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 48 hours following drug administration
Number of subjects with clinically significant changes in vital signs
Blood pressure, Pulse Rate
Time frame: up to 48 hours following drug administration
Number of subjects with adverse events
Time frame: up to 48 hours following drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
Time frame: up to 48 hours following drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: after 48 hours following drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 48 hours following drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 48 hours following 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 48 hours following drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 48 hours following drug administration
λz (terminal rate constant in plasma)
Time frame: up to 48 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 48 hours following drug administration
MRT (Mean time of residence of drug molecules in the body after intravascular administration)
Time frame: up to 48 hours following drug administration
Vz/F (Apparent volume of distribution during the terminal phase after extravascular administration)
Time frame: up to 48 hours following drug administration
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