The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Number of patients with adverse events
Time frame: up to day 14
Number of patients with clinically significant findings in vital signs
blood pressure, pulse rate, body temperature, orthostatic test
Time frame: up to 10 days after last drug administration
Number of patients with clinically significant findings in ECG
Time frame: up to 10 days after last drug administration
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 10 days after last drug administration
Assessment of tolerability by the investigator on a four-point scale
Time frame: up to 10 days after last drug administration
Maximum measured concentration of the analyte in plasma at different time points (Cmax)
Time frame: up to day 13
time from dosing to maximum measured concentration of the analyte at different time points (tmax)
Time frame: up to day 13
Area under the concentration-time curve of the analyte in the plasma over time interval from 0 to the last measurable time point of the dose at different time points (AUC0-tz)
Time frame: up to day 13
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity at different time points (AUC0-∞)
Time frame: up to day 13
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Percentage of the AUC0-∞ that is obtained by extrapolation at different time points (%AUCtz-∞)
Time frame: up to day 13
Terminal phase elimination rate constant at different time points (λz)
Time frame: up to day 13
Mean residence time of the analyte in the body after oral administration at different time points (MRTpo)
Time frame: up to day 13
Terminal phase elimination half life at different time points (t1/2)
Time frame: up to day 13
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/Fss)
Time frame: up to day 13
Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/Fss)
Time frame: up to day 13
Minimum plasma concentration at steady state (Cmin,ss)
Time frame: up to day 13
Dose-normalized Cmax at steady state (Cmax/Dss)
Time frame: up to day 13
Dose-normalised AUC0-∞ at steady state (AUC0-∞/Dss)
Time frame: up to day 13
Accumulation index of the analyte when comparing AUCτ (RA,AUCτ)
Time frame: up to day 13
Accumulation index of the analyte when comparing Cmax (RA,Cmax)
Time frame: up to day 13
Linearity index (LI)
Time frame: up to day 13
Amount of analyte excreted in urine unchanged from t1 to t2 interval at different time points (Aet1-t2)
Time frame: up to day 11
Renal clearance of the unchanged analyte at different time points (CLr)
Time frame: up to day 11
Area under the serum biomarker concentration-time curve after the Nth dose (AUECN)
Time frame: up to day 13
Area under the baseline (before dose level) but above serum biomarker concentration-time curve after the Nth dose (AUECbelow_base)
Time frame: up to day 13
Minimum measured serum concentration of the biomarkers after the Nth dose (Emin,N)
Time frame: up to day 13
Maximum measured serum concentration of the biomarkers after the Nth dose (Emax,N)
Time frame: up to day 13
Serum biomarker concentration after the (N-1)th dose but before the Nth dose (Epre,N)
Time frame: up to day 13
Measured value of the biomarkers in biological matrix at the set time point after Nth dose (EN)
Time frame: up to day 13
Oral glucose insulin sensitivity (OGIS) index
Time frame: up to day 13
Homeostasis model assessment (HOMA) value
Time frame: up to day 13