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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022697-14 | EudraCT Number | EudraCT |
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The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 135585 (T) | Experimental | single dose per subject as tablet formulation after high fat, high caloric meal |
|
| BI 135585 (R) | Experimental | single dose per subject as tablet formulation after an overnight fast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 135585 | Drug | one oral single dose per subject |
| |
| BI 135585 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity | up to 144 hours post treatment | |
| Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity | up to 144 hours post treatment |
| 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) | up to 144 hours post treatment | |
| Physical examination (occurrence of findings) | up to 14 days post treatment |
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Inclusion criteria:
- healthy male subjects
Exclusion criteria:
- 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 |
|---|---|---|---|---|---|---|
| 1283.3.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Term |
|---|---|
| C000600796 | 6-(2-hydroxy-2-methylpropyl)-3-(1-(4-(1-methyl-2-oxo-1,2-dihydropyridin-4-yl)phenyl)ethyl)-6-phenyl-1,3-oxazinan-2-one |
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| Drug |
one oral single dose per subject |
|
| %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation) | up to 144 hours post treatment |
| tmax (time from dosing to maximum measured concentration) | up to 144 hours post treatment |
| λz (terminal rate constant in plasma) | up to 144 hours post treatment |
| t1/2 (terminal half-life of the analyte in plasma) | up to 144 hours post treatment |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 144 hours post treatment |
| CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) | up to 144 hours post treatment |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 144 hours post treatment |
| Vital signs (blood pressure, pulse rate) | up to 14 days post treatment |
| 12-lead ECG (electrocardiogram) | up to 14 days post treatment |
| Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis) | up to 14 days post treatment |
| Incidence and severity of Adverse events | up to 14 days post treatment |
| Assessment of tolerability by the investigator | up to 14 days post treatment |