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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000312-21 | EudraCT Number | EudraCT |
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To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 187004 dose 1 | Experimental | multiple dose given over 14 days |
|
| BI 187004 dose 2 | Experimental | multiple dose given over 14 days |
|
| BI 187004 dose 3 | Experimental | multiple dose given over 14 days |
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| BI 187004 dose 4 | Experimental | multiple dose given over 14 days |
|
| BI 187004 dose 5 | Experimental | multiple dose given over 14 days |
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| BI 187004 dose 6 | Experimental | multiple dose given over 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo |
| |
| BI 187004 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | up to 15 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) | up to 8 days postdose | |
| Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose) |
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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 |
|---|---|---|---|---|---|---|
| 1307.2.1 Boehringer Ingelheim Investigational Site | Neuss | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36343645 | Derived | Bianzano S, Schepers C, Wolff M, Heise T, Plum-Moerschel L. Selective Inhibition of 11beta-Hydroxysteroiddehydrogenase-1 with BI 187004 in Patients with Type 2 Diabetes and Overweight or Obesity: Safety, Pharmacokinetics, and Pharmacodynamics After Multiple Dosing Over 14 Days. Exp Clin Endocrinol Diabetes. 2022 Dec;130(12):773-782. doi: 10.1055/a-1932-3136. Epub 2022 Nov 7. |
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| Placebo |
| Placebo Comparator |
placebo |
|
| BI 187004 dose 7 | Experimental | multiple dose given over 14 days |
|
| Drug |
BI 187004, dose 2 |
|
| BI 187004 | Drug | BI 187004, dose 4 |
|
| BI 187004 | Drug | BI 187004, dose 5 |
|
| BI 187004 | Drug | BI 187004, dose 6 |
|
| BI 187004 | Drug | BI 187004, dose 7 |
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| BI 187004 | Drug | BI 187004, dose 1 |
|
| BI 187004 | Drug | BI 187004, dose 3 |
|
| up to 8 days postdose |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) | up to 8 days postdose |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) | up to 8 days postdose |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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