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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005029-22 | EudraCT Number | EudraCT |
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To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug | single dose of midazolam given as oral solution (day 1 of visits 2 and 3) |
| |
| 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) for probe substrates | up to 143 hours postdose | |
| Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates | up to 143 hours postdose |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1307.19.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| caffeine |
| Drug |
single dose of caffeine given as tablets (day 1 of visits 2 and 3) |
|
| digoxin | Drug | single dose of digoxin given as tablets (day 3 of visits 2 and 3) |
|
| warfarin | Drug | single dose of warfarin given as tablets (day 1 of visits 2 and 3) |
|
| omeprazole | Drug | single dose of omeprazole given as tablet (day 1 of visits 2 and 3) |
|
| BI 187004 | Drug | multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3) |
|
| metoprolol | Drug | single dose of metoprolol given as tablets (day 1 of visits 2 and 3) |
|
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D002110 | Caffeine |
| D004077 | Digoxin |
| D014859 | Warfarin |
| D009853 | Omeprazole |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
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