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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003310-27 | EudraCT Number |
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The primary objective of this trial is to investigate the relative bioavailability of BI 685509 given alone under fasted conditions (Reference, R) compared to the intake after a high fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted conditions (Test 3, T3).
The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
BI 685509 is a substrate of the drug transporters P-gp and Organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1/OATP1B3). Inhibition of these transport proteins may result in an increased drug exposure which might impact the safety of the patients. Therefore this trial should investigate whether and to what extent the inhibition of P-gp (mediated by itraconazole) and the inhibition of OATP1B1/OATP1B3 (mediated by rifampin) affects kinetics of BI 685509. Itraconazole and rifampin are recommended probe drugs to test in-vivo inhibition of P-gp and OATP1B1/OATP1B3.
Furthermore the food effect will be investigated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Treatment | Experimental | BI 685509 given alone, fasted |
|
| Treatment 1 | Experimental | BI 685509, given alone, after a high fat, high calorie breakfast |
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| Treatment 2 | Experimental | BI 685509, given together with itraconazole, fasted |
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| Treatment 3 | Experimental | BI 685509, given together with rifampicin, fasted |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 685509 After Standardised Breakfast | Drug | High-fat high calorie breakfast |
| |
| 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 last quantifiable data point) | AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) | 4 Days |
| Cmax (maximum measured concentration of the analyte in plasma) | Cmax (maximum measured concentration of the analyte in plasma) | 4 Days |
| 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) | AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 4 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole |
| Drug |
Administration of itraconazole together with BI 685509 |
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| Rifampin | Drug | Administration of rifampicin together with BI 685509 |
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| BI 685509 Fasted Conditions | Drug | BI 685509, given alone |
|
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |