The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
SGS Life Science Services - Clinical Research
Antwerp, Belgium
Percentage of Subjects With Drug Related Adverse Events
Percentage of subjects with drug related adverse events are presented.
Time frame: Adverse events reported until the end-of-trial examination; up to day 74
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)
Maximum measured concentration of BI 655130 in plasma (Cmax) is presented.
Time frame: -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. Reliable values of AUC0-∞ could not be calculated because concentrations were too high at the last PK sample collected "1680h" after drug administration. AUC0-tz was utilized for the dose proportionality analyses instead of AUC0-∞.
Time frame: -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 to the Last Measurable Plasma Concentration (AUC0-tz)
Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 to the last measurable plasma concentration (AUC0-tz) is presented.
Time frame: -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration
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