To assess the metabolic profile, to obtain the mass balance after oral administration, to determine the concentration of \[14C\]-radioactivity in blood cells, plasma, urine and faeces, to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if feasible, to determine the protein binding of \[14C\]-radioactivity, to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a single oral administration of \[14C\]-BIBF 1120 in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
[14C]-radioactivity in plasma and whole blood (C Blood cells/C plasma ratio of [14C]-radioactivity)
Time frame: Up to 96 h after drug administration
[14C]-radioactivity in urine
Time frame: Up to 120 h after drug administration
Measurement of the plasma protein binding of total [14C]-radioactivity in human plasma samples ex vivo
Time frame: Up to 96 h after drug administration
Maximum observed concentration of the analyte in plasma (Cmax)
Time frame: Up to 96 h after drug administration
Plasma concentration-time profiles of total radioactivity in whole blood and plasma
Time frame: Up to 96 h after drug administration
[14C]-metabolic profile and identification of metabolites in urine, in comparison with various animal species
Time frame: Up to 120 h after drug aministration
[14C]-radioactivity in faeces
Time frame: up to 120 h after administration
[14C]-metabolic profile and identification of metabolites in faeces, in comparison with various animal species
Time frame: Up to 120 h after drug aministration
[14C]-metabolic profile and identification of metabolites in plasma, in comparison with various animal species
Time frame: Up to 96 h after drug aministration
Time from dosing to peak concentration (tmax)
Time frame: Up to 96 h after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 96 h after drug administration
Terminal rate constant of the analyte in plasma (λz)
Time frame: Up to 96 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
Time frame: Up to 24 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
Time frame: Up to 96 h after drug administration
Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)
Time frame: Up to 96 h after drug administration
Mean residence time of the analyte molecules in the body after oral administration (MRTpo)
Time frame: Up to 96 h after drug administration
Total clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 96 h after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Time frame: Up to 96 h after drug administration
Fraction of analyte eliminated in urine from 0 to the limit of the last quantifiable data point (fe0-tz)
Time frame: Up to 96 h after drug administration
Fraction of analyte eliminated in faeces from 0 to the limit of the last quantifiable data point (fe faeces,0-tz)
Time frame: Up to 96 h after drug administration
Amount of analyte that was eliminated in faeces from 0 to the limit of the last quantifiable data point (Ae faeces,0-tz)
Time frame: Up to 96 h after drug administration
Amount of analyte that was eliminated in urine from 0 to the limit of the last quantifiable data point (Ae0-tz)
Time frame: Up to 96 h after drug administration
Change from baseline in vital signs
Time frame: Baseline, day 14 after drug administration
Change from baseline in routine laboratory
Time frame: Baseline, day 14 after drug aministration
Number of participants with adverse events
Time frame: Up to day 14 after drug aministration
Change from baseline in electrocardiogram
Time frame: Baseline, day 14 after drug aministration
Assessment of tolerability by investigator according a 4 point scale
Time frame: Day 14 after drug administration