In order to assess the potential impact of steady state BI 425809 on CYP3A clinically, the effect of BI 425809 on the midazolam pharmacokinetics will be evaluated. Midazolam is a recommended substrate of CYP3A4.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
midazolam
BI 425809
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Time frame: Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).
Maximum Measured Concentration of Midazolam in Plasma (Cmax)
Maximum measured concentration of midazolam in plasma (Cmax) is presented.
Time frame: Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.
Time frame: Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).
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