Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 Tablets in Otherwise Healthy Controlled Asthmatic Subjects (Phase I, Randomised, Placebo-controlled, Double-blind Within Dose Groups)

简要总结

主要结局

次要结局

• Cmax (maximum measured concentration of the analyte in plasma)(up to 481:30 h)
• tmax (time from dosing to maximum measured concentration of the analyte in plasma)(up to 481:30 h)
• AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)(up to 481:30 h)
• 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 within the first dosing interval)(up to 481:30 h)
• AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 481:30 h)
• Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered(up to 481:30 h)
• terminal rate constant in plasma(up to 481:30 h)
• MRTpo (mean residence time of the analyte in the body after oral administration)(up to 481:30 h)
• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)(up to 481:30 h)
• tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)(up to 481:30 h)
• Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t)(up to 481:30 h)
• AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)(up to 481:30 h)
• terminal rate constant in plasma at steady state(up to 481:30 h)
• t1/2,ss (terminal half-life of the analyte in plasma at steady state)(up to 481:30 h)
• MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)(up to 481:30 h)
• CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)(up to 481:30 h)
• Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)(up to 481:30 h)
• Cavg (average concentration)(up to 481:30 h)
• PTF (peak trough fluctuation)(up to 481:30 h)