The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
BI 207127 as a single dose after a high fat breakfast
BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day
BI 207127 as a single dose in fasted state
1241.44.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany
AUC(0-tz)
Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
Cmax
Maximum measured concentration of deleobuvir in plasma (Cmax)
Time frame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
AUC(0-inf)
Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BI 207127 as a single dose after a low fat breakfast