BI 764198 is intended to be used in patients hospitalized for COVID-19 at risk of respiratory complications. The present trial will investigate the relative bioavailability of BI 764198 administered as capsules versus tablets in a first part, and the relative bioavailability and food effect of four oral formulations: the newly developed tablet formulation under fed and fasted conditions as well as suspension from capsules and suspension from tablets in a second part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
BI 764198
BI 764198
BI 764198
SGS Belgium NV Research Unit Stuivenberg
Antwerp, Belgium
Part 1: 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)
Time frame: up to 4 days per period
Part 1: Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 4 days per period
Part 2: 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)
Time frame: up to 5 days per period
Part 2: Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 5 days per period
Part 1: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 4 days per period
Part 2: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 5 days per period
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BI 764198