To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
single rising doses
single rising doses
1345.1.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events
Time frame: AEs were recorded throughout the trial
Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration
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