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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003225-21 | EudraCT Number | EudraCT |
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This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 144807 | Experimental | subjects receive an oral single dose of BI 144807 |
|
| BI 144807 plus Ketoconazole | Experimental | subjects receive bid ketoconazole plus an oral single dose of BI 144807 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketoconazole | Drug | Ketoconazole 400 mg / day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity | 0 to 48 hours after administration | |
| Maximum measured concentration of the analyte in plasma | 0 to 48 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point | 0 to 48 hours after administration |
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Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1313.7.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| BI 144807 |
| Drug |
BI144807 oral solution, intermediate dose |
|
| BI 144807 | Drug | BI144807 oral solution, intermediate dose |
|