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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018542-31 | EudraCT Number | EudraCT |
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The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 113823 | Experimental | single oral dose per subject |
|
| BI 113823 + Ketokonazole | Experimental | after wash-out 5 days ketokonazole with BI 113823 on day 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 113823 + Ketokonazole | Drug | 5 days ketokonazole with single oral dose of BI 113823 on day 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823 | 2 weeks | |
| Cmax (maximum measured concentration of the analyte in plasma) of BI 113823 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks | |
| Number of participants with clinically significant changes in physical examination | up to 24 days |
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Inclusion criteria:
healthy male subjects
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1272.5.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| BI 113823 | Drug | single oral dose |
|
| Number of participants with clinically significant changes in vital signs | up to 24 days |
| Number of participants with clinically significant changes in ECG | up to 24 days |
| Number of participants with clinically significant changes in laboratory tests | up to 24 days |
| Occurrence of adverse events | up to 24 days |
| Assessment of tolerability by the investigator | up to 24 days |
| AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) | 2 weeks |
| AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax | 2 weeks |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | 2 weeks |
| λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma | 2 weeks |
| t1/2 (terminal half-life of the analyte in plasma) | 2 weeks |
| MRTpo (mean residence time of the analyte in the body after po administration) | 2 weeks |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | 2 weeks |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | 2 weeks |
| Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24) | visit 2, day 1 and visit 4 day 1 |
| fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24 | visit 2, day 1 and visit 4 day 1 |
| CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24) | visit 2, day 1 and visit 4 day 1 |