Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Steady-state Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to day 31
Steady-state AUC (Area under concentration-time curve)
Time frame: up to day 31
Cmax for several time points
Time frame: up to day 31
Tmax (Time from dosing to the maximum measured concentration of the analyte in plasma)
Time frame: up to day 31
Cx for several time points
Time frame: up to day 31
AUC for several time points
Time frame: up to day 31
CL/F (Total apparent clearance of the analyte in plasma following extravascular administration) for several time points
Time frame: up to day 31
V/F (Apparent volume of distribution during following an extravascular dose) for several time points
Time frame: up to day 31
t1/2 (Terminal half-life of the analyte in plasma)
Time frame: up to day 31
Cavg0-24
Time frame: up to day 31
Ratio for Cmax,Met at several time points
Time frame: up to day 31
Ratio for AUC at several time points
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Days 1, 7, 23 and 29
Time frame: up to day 31
Tlast,N
Time frame: up to day 31
Ae (amount of analyte eliminated in urine for different time points)
Time frame: up to day 29
CLR (renal clearance of the analyte for different time points)
Time frame: up to day 29
fe (fraction of analyte eliminated in urine for different time points)
Time frame: up to day 29
Number of patients with adverse events
Time frame: up to 66 days
Assessment of tolerability on a 4-pointe scale by investigator
Time frame: within 14 days after last drug administration