The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to \[C-14\]-BI 425809 administered as intravenous microtracer (Reference, R).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
One 25 mg film coated tablet administered with 240 milliliters of water after an overnight fast of at least 10 hours.
Intravenous micro-tracer infusion of 30 μg BI 425809 (14-C) administered 4 hours after treatment T.
ICON
Groningen, Netherlands
Area Under the Concentration-time Curve of the Analyte ([14C]-BI 425809 After iv Administration as Well as for BI 425809 After Oral Administration) Over the Time Interval From 0 to Infinity (AUC0-∞, Norm)
The dose-normalised area under the concentration-time curve of the analyte (\[14C\]-BI 425809 after iv administration as well as for BI 425809 after oral administration) over the time interval from 0 to infinity (AUC0-∞, norm) is presented. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model performed on the logarithmic scale, including 'formulation' as a fixed effect and 'subject' as a random effect. For treatment T, pharmacokinetic samples were collected within 2 h prior to the drug administration and at 1, 2, 3, 4.083, 6, 8, 12, 24, 72, 120 and at 168 h after single oral administration of unlabelled BI 425809. For treatment R, samples were collected at 3, 4.083, 4.167, 4.25, 4.5, 5, 6, 7, 8, 12, 16, 24, 72, 120 and 168 h after single oral administration of unlabelled BI 425809.
Time frame: Pharmacokinetic samples were collected within 2 h before and up to 168 h after single oral administration of unlabelled BI 425809. Further details are in description.
Maximum Measured Concentration of the BI 425809 in Plasma After a Single Oral Dose (Cmax)
Cmax, maximum measured concentration of the BI 425809 in plasma after a single oral dose is presented.
Time frame: Pharmacokinetic samples were collected within 2:00 h:m prior to the drug administration and at 1:00, 2:00, 3:00, 4:05, 6:00, 8:00, 12:00, 24:00, 72:00, 120:00 and at 168:00 h:m after drug administration.
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