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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001549-19 | EudraCT Number |
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The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects.
The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Arm 1 | Experimental |
| |
| Part B: Arm 1 - Reference | Experimental |
| |
| Part B: Arm 2 - Treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C] BI 685509 formulation 1 | Drug | [¹⁴C] BI 685509 formulation 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: fraction of [¹⁴C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz) | up to 14 days | |
| Part A: fraction of [¹⁴C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces,0-tz) | up to 14 days | |
| Part B: Absolute bioavailability of BI 685509 (%, obtained from a ratio of dose normalised values of AUCo-∞ after [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 administration) | AUCo-∞: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity | up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC₀-tz) | up to 14 days | |
| Part A: Maximum measured concentration of the analyte in plasma (Cₘₐₓ) | up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41489441 | Derived | Joseph D, Wong D, Mitra P, Auclair AM, Wolfgang T, Gao E, Herich L, Tiessen R. Mass balance and absolute bioavailability of avenciguat (14C) after intravenous or oral administration in healthy male participants. Expert Opin Investig Drugs. 2026 Jan;35(1):75-84. doi: 10.1080/13543784.2025.2612329. Epub 2026 Jan 13. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency
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The study has two parts:
Part A: open-label, single-arm, single dose trial, Part B: non-randomised, open-label, fixed sequence crossover trial.
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| [¹⁴C] BI 685509 formulation 2 |
| Drug |
[¹⁴C] BI 685509 formulation 2 |
|
| BI 685509 formulation 3 | Drug | BI 685509 formulation 3 |
|
| Part B: Area under the concentration-time curve of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma over the time interval from 0 to the last quantifiable time point (AUC₀-tz) | up to 4 days |
| Part B: Area under the concentration-time curve of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma over the time interval from 0 extrapolated to infinity (AUC₀-∞) | up to 4 days |
| Part B: Maximum measured concentration of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma (Cₘₐₓ) | up to 4 days |