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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000320-20 | EudraCT Number | EudraCT |
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Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed by iohexol clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
The secondary objective of this trial is to investigate the glomerular filtration rate (GFR) as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1060469 low dose | Experimental | Low-Dose,Tablet,oral administration with 240 ml water,over 10 days |
|
| BI 1060469 high dose | Experimental | High-Dose,Tablets,oral administration with 240 ml water, over 10 days |
|
| Cimetidine | Active Comparator |
| |
| Naproxen | Active Comparator |
| |
| BI 1021958 | Experimental | High-Dose,Tablets,oral administration with 240 ml water, over 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | tablets |
| |
| Cimetidine |
| Measure | Description | Time Frame |
|---|---|---|
| measured glomerular filtration rate (mGFR) based on renal iohexol clearance | up to day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| measured urinary 24-hour creatinine clearance | up to day 11 |
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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 |
|---|---|---|---|---|---|---|
| 1333.43.1 Boehringer Ingelheim Investigational Site | Berlin | Germany |
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| ID | Term |
|---|---|
| D002927 | Cimetidine |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 |
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| Drug |
|
| Placebo | Drug | tablets |
|
| Placebo | Drug | tablets |
|
| BI 1060469 high dose | Drug | tablets |
|
| BI 1060469 low dose | Drug | tablets |
|
| Naproxen | Drug |
|
| BI 1021958 | Drug | tablets |
|
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |