Study to determine the pharmacokinetics of BI 10773 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of \[14C\] BI 10773
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Cmax (maximum concentration of the analyte in plasma)
Time frame: pre-dose and up to 144 hours after administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: pre-dose and up to 144 hours after administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: pre-dose and up to 144 hours after administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)
Time frame: pre-dose and up to 144 hours after administration
λz (terminal rate constant in plasma)
Time frame: pre-dose and up to 144 hours after administration
t1/2 (terminal half-life of the analyte(s) in plasma)
Time frame: pre-dose and up to 144 hours after administration
MRTpo (mean residence time of the analyte(s) in the body after oral administration)
Time frame: pre-dose and up to 144 hours after administration
CL/F (apparent/total clearance of the analyte(s) in plasma after an extravascular dose)
Time frame: pre-dose and up to 144 hours after administration
Vz/F (apparent volume of distribution during the terminal phase λz after an extravascular dose)
Time frame: pre-dose and up to 144 hours after administration
feurine,0-tz (amount of analyte excreted in urine over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: pre-dose and up to 168 hours after administration
fefaeces,0-tz (amount of analyte excreted in faeces over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated)
Time frame: pre-dose and up to 168 hours after administration
CLR,0-tz (renal clearance of analyte)
Time frame: pre-dose and up to 168 hours after administration
Individual concentration-time profiles of [14C] radioactivity in whole blood, plasma, urine, and faeces
Time frame: up to 8 days
Individual concentration-time profiles of BI 10773 in plasma and urine
Time frame: up to 8 days
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time frame: up to 8 days
Identification of major metabolites in urine, faeces, and plasma
Time frame: up to 8 days
Cblood cell/Cplasma ratio of [14C]-radioactivity
Time frame: up to 8 days
Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo
Time frame: up to 8 days
Number of patients with abnormal findings in physical examination
Time frame: Baseline and within 6 days after discharge
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: Baseline, days 1, 2, 7 and within 6 days after discharge
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Time frame: Baseline, days 1, 2, 7 and within 6 days after discharge
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline, days 1, 2 and within 6 days after discharge
Number of patients with adverse events
Time frame: Up to 22 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 8