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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-BI 10773 - oral solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-BI 10773 - oral solution | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | pre-dose and up to 144 hours after administration | |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | 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) | 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) | pre-dose and up to 144 hours after administration | |
| λz (terminal rate constant in plasma) | pre-dose and up to 144 hours after administration | |
| t1/2 (terminal half-life of the analyte(s) in plasma) | pre-dose and up to 144 hours after administration | |
| MRTpo (mean residence time of the analyte(s) in the body after oral administration) | pre-dose and up to 144 hours after administration | |
| CL/F (apparent/total clearance of the analyte(s) in plasma after an extravascular dose) | pre-dose and up to 144 hours after administration | |
| Vz/F (apparent volume of distribution during the terminal phase λz after an extravascular dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with abnormal findings in physical examination | Baseline and within 6 days after discharge | |
| Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) | Baseline, days 1, 2, 7 and within 6 days after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| 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) | 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) | pre-dose and up to 168 hours after administration |
| CLR,0-tz (renal clearance of analyte) | pre-dose and up to 168 hours after administration |
| Individual concentration-time profiles of [14C] radioactivity in whole blood, plasma, urine, and faeces | up to 8 days |
| Individual concentration-time profiles of BI 10773 in plasma and urine | up to 8 days |
| Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces | up to 8 days |
| Identification of major metabolites in urine, faeces, and plasma | up to 8 days |
| Cblood cell/Cplasma ratio of [14C]-radioactivity | up to 8 days |
| Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo | up to 8 days |
| Number of patients with abnormal findings in 12-lead electrocardiogram (ECG) | Baseline, days 1, 2, 7 and within 6 days after discharge |
| Number of patients with abnormal changes in laboratory parameters | Baseline, days 1, 2 and within 6 days after discharge |
| Number of patients with adverse events | Up to 22 days |
| Assessment of tolerability by investigator on a 4-point scale | Day 8 |