The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Oral single dose of BI 409306
Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole
1289.23.8201 Boehringer Ingelheim Investigational Site
Seoul, South Korea
AUC0-infinity of BI 409306 and Its Metabolites
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Cmax of BI 409306 and Its Metabolites
Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
AUC0-tz of BI 409306 and Its Metabolites
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz) of BI 409306 and its metabolites CD 13896 and CD 14084
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Tmax of BI 409306 and Its Metabolites
Time from dosing to the maximum concentration of the analyte in plasma (tmax) of BI 409306 and its metabolites CD 13896 and CD 14084
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
t1/2 of BI 409306 and Its Metabolites
Terminal half-life of the analyte in plasma (t1/2) of BI 409306 and its metabolites CD 13896 and CD 14084
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Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration