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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004540-35 | EudraCT Number |
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The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses.
Secondary objectives are the exploration of the pharmacokinetics (PK), dose proportionality, the attainment of steady state, as well as investigation of linearity and pharmacodynamics (PD) of BI 685509 after multiple dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 685509 | Experimental | multiple rising doses of BI 685509 |
|
| Placebo | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 685509 | Drug | to be given for a total of up to 15 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with drug-related Adverse Events | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC tau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) [AUC tau,1 will be AUC0-24 for QD] | up to 24 hours | |
| Cmax (maximum measured concentration of the analyte in plasma) |
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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 |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | 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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| Placebo |
| Drug |
to be given for a total of up to 15 days |
|
| up to 72 hours |
| AUC tau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) [AUC tau,ss will be AUC0-12,ss for bid and AUC0-24,ss for QD] | up to 408 hours |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) | up to 408 hours |