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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002668-15 | EudraCT Number |
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This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation/BAY1834845 | Experimental | Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day |
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| Placebo | Placebo Comparator | Subjects will receive a single dose of placebo in the morning of the PK profile day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1834845 | Drug | Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment-emergent adverse events (TEAEs) | AEs are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Up to 25 days after last drug administration |
| Severity of treatment-emergent adverse events | The intensity of an AE is classified according to the following categories:
| Up to 25 days after last drug administration |
| Area under the plasma concentration vs. time curve (AUC) | AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast) | Baseline to up to 14 days post drug administration |
| Maximum drug concentration in plasma after single dose administration (Cmax) | Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845 | Baseline to up to 14 days post drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40520205 | Derived | Feldmuller M, Jodl SJ, Ploeger B, Wagenfeld A, Wiesinger H, Zollmann FS, Klein S, Zhang R, Rohde B, Hochel J. Zabedosertib, a novel interleukin-1 receptor-associated kinase-4 inhibitor, shows a favorable pharmacokinetic and safety profile across multiple phase 1 studies. Front Pharmacol. 2025 May 30;16:1521505. doi: 10.3389/fphar.2025.1521505. eCollection 2025. |
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| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D034161 | Pelvic Infection |
| D007239 | Infections |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| C000723917 | zabedosertib |
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| Placebo | Drug | Single dose of placebo |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |