The primary objective of this trial is to investigate the relative bioavailability of a single dose of BI 425809 when given alone (Reference, B) compared with co-administration (Test, A) on the 7th day of a 10-day treatment with rifampicin following oral administration in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
once daily
once daily
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Area Under the Plasma Concentration-time Curve From 0 to 168 Hours Time Point of BI 425809 (AUC0-168).
This endpoint calculates area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 168 hour time point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including subject as random effect and treatment as fixed effect.
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
Maximum Concentration of BI 425809 in Plasma (Cmax).
This outcome is maximum measured concentration of the BI 425809 in plasma.
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
Area Under the Concentration-time Curve of BI 425809 in Plasma With and Without Co-administration of Rifampicin Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
This endpoint calculates area under the concentration-time curve of BI 425809 in plasma with and without adminstration of Rifampicin over the time interval from 0 extrapolated to infinity.
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.
Terminal Half-life of the Metabolite BI 761036 in Plasma (t1/2)
Half life is the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount.
Time frame: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 3:00, 6:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 168:00, 216:00, 264:00, 336:00, 408:00, 504:00, 576:00, 672:00, 744:00, 840:00 and 1008:00 hours post dose.
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