Study to assess the influence of severe renal impairment on the pharmacokinetics (PK), safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by inhalation with the Respimat® Inhaler)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
AUC0-4 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 4 hours after dosing)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
%AUCtz-∞ (percentage of area under the concentration-time curve obtained by extrapolation)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
λz (terminal rate constant in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
MRTih (mean residence time of the analyte in the body after inhalation)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to t2)
Time frame: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
fet1-t2 (fraction of analyte excreted in urine from the time point t1 to t2)
Time frame: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Time frame: before and at 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
Plasma protein binding of BI 1744 BS
Time frame: before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration
Number of patients with adverse events
Time frame: up to 5 weeks
Assessment of tolerability on a 4-point scale by the investigator
Time frame: within 5 to 14 days after drug administration