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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004455-31 | EudraCT Number | EudraCT |
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To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising oral doses of BI 685509
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 685509 | Experimental |
| |
| Placebo | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 685509 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number [N(%)] of the subject with drug-related Adverse Events | 0-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 0-24 hours | |
| Cmax (maximum concentration of the analyte in plasma) | 0-24 hours |
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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 |
|---|---|---|---|---|---|---|
| 1366.1.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38789635 | Derived | Wong D, Seitz F, Bauer V, Giessmann T, Schulze F. Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509, a soluble guanylyl cyclase activator, in healthy volunteers: Results from two randomized controlled trials. Naunyn Schmiedebergs Arch Pharmacol. 2024 Oct;397(10):8101-8116. doi: 10.1007/s00210-024-03165-w. Epub 2024 May 24. |
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