A Randomised, Double-blind (Within Dose Groups), Parallel Group, Placebocontrolled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinese Healthy Male Volunteers and Multiple Rising Doses (50 mg b.i.d., 200 mg b.i.d., 400 mg b.i.d.) of BI 671800 HEA in Japanese Healthy Male Volunteers

简要总结

主要结局

次要结局

• SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957(up to 4 days)
• SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957(up to 4 days)
• SRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957(up to 4 days)
• SRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) BI 671800 and BI 600957(up to 4 days)
• SRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), BI 671800 and BI 600957(up to 4 days)
• SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957(up to 4 days)
• SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957(up to 4 days)
• SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957(up to 4 days)
• SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957(up to 4 days)
• SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800(up to 4 days)
• SRD Part, Vz/F (apparent volume of distribution during the terminal phase λ z following an oral dose); only BI 671800(up to 4 days)
• MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) , BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957(day1 Visit2, day1 Visit3)
• MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800(day1 Visit2, day1 Visit 3)
• MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957(up to 12 days)
• MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800(day1 Visit2, day1 Visit3)
• MRD Part, Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957(up to 12 days)
• Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800(up to 12 days)
• Linearity index (LI) of the analyte in plasma(up to 12 days)
• AUEC0-24,N percent inhibition of eosinophil shape change: area under the percent inhibition of shape change - time curve after the Nth dose of BI 671800(up to day 9)
• MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957(up to 12 days)
• MRD Part, Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, BI 671800 and BI 600957(up to 12 days)
• MRD Part,AUCt1-t2,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time interval t1 to t2) BI 671800 and BI 600957(up to 12 days)
• MRD Part,AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957(up to 12 days)
• CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800(up to 12 days)
• Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state(up to 12 days)
• AUEC0-24,N absolute inhibition of eosinophil shape change: area under the absolute inhibition of shape change-time curve after the Nth dose of BI 671800 HEA(up to day 9)
• Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state(up to 12 days)
• MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957(up to 12 days)
• MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957(up to 12 days)
• MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957(up to 12 days)
• MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957(up to 12 days)