Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBF 1120 ES | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBF 1120 ES | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| [14C]-radioactivity in plasma and whole blood (C Blood cells/C plasma ratio of [14C]-radioactivity) | Up to 96 h after drug administration | |
| [14C]-radioactivity in urine | Up to 120 h after drug administration | |
| Measurement of the plasma protein binding of total [14C]-radioactivity in human plasma samples ex vivo | Up to 96 h after drug administration | |
| Maximum observed concentration of the analyte in plasma (Cmax) | Up to 96 h after drug administration | |
| Plasma concentration-time profiles of total radioactivity in whole blood and plasma | Up to 96 h after drug administration | |
| [14C]-metabolic profile and identification of metabolites in urine, in comparison with various animal species | Up to 120 h after drug aministration | |
| [14C]-radioactivity in faeces | up to 120 h after administration | |
| [14C]-metabolic profile and identification of metabolites in faeces, in comparison with various animal species | Up to 120 h after drug aministration | |
| [14C]-metabolic profile and identification of metabolites in plasma, in comparison with various animal species | Up to 96 h after drug aministration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in vital signs | Baseline, day 14 after drug administration | |
| Change from baseline in routine laboratory | Baseline, day 14 after drug aministration | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time from dosing to peak concentration (tmax) | Up to 96 h after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | Up to 96 h after drug administration |
| Terminal rate constant of the analyte in plasma (λz) | 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) | 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) | Up to 96 h after drug administration |
| Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞) | Up to 96 h after drug administration |
| Mean residence time of the analyte molecules in the body after oral administration (MRTpo) | Up to 96 h after drug administration |
| Total clearance of the analyte in plasma following extravascular administration (CL/F) | Up to 96 h after drug administration |
| Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F) | 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) | 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) | 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) | 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) | Up to 96 h after drug administration |
| Number of participants with adverse events |
| Up to day 14 after drug aministration |
| Change from baseline in electrocardiogram | Baseline, day 14 after drug aministration |
| Assessment of tolerability by investigator according a 4 point scale | Day 14 after drug administration |