A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Phase I - Study to a) Assess Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses 2 mg to 600 mg of BI 660848 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of an Immediate Release Tablet Formulation and c) to Assess the Impact of a High Fat Meal on the Oral Bioavailability of the Oral Drinking Solution (Powder in Bottle).

简要总结

主要结局

次要结局

• Cmax (maximum measured concentration of the analyte in plasma)(3 days)
• CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(3 days)
• tmax (time from dosing to maximum measured concentration)(3 days)
• Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)(3 days)
• Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(3 days)
• AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(3 days)
• t1/2 (terminal half-life of the analyte in plasma)(3 days)
• MRT (mean residence time of the analyte in the body after drug intake)(3 days)
• CL/F (apparent clearance of the analyte in plasma after extravascular administration)(3 days)
• fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2)(3 days)