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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004393-18 | EudraCT Number |
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This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral BAY1834845 | Experimental | Study Part A, cross over sequence:
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| Oral BAY1834845 + i.v. BAY1834845 | Experimental | Study Part A, cross over sequence:
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| Oral Methotrexate | Experimental | Study part B, cross over sequence:
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| Oral Methotrexate + oral BAY1834845 | Experimental | Study part B, cross over sequence:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1834845 | Drug | Single oral dose (IR [immediate release] tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (Area under the concentration-versus-time curve from zero to infinity after single (first) dose) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state | in study part A | Multiple timepoints up to day 7 |
| Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state | in study part A | Multiple timepoints up to day 7 |
| Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration | in study part A | Multiple timepoints up to day 7 |
| Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration | in study part A | Multiple timepoints up to day 7 |
| Absolute oral bioavailability (F) of BAY1834845 in the fasted state | in study part A | Multiple timepoints up to day 7 |
| AUC of methotrexate in plasma in presence/absence of BAY1834845 | in study part B | Multiple timepoints up to day 2 |
| Cmax of methotrexate in plasma in presence/absence of BAY1834845 | in study part B | Multiple timepoints up to day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Treatment Emergent Adverse Events (TEAEs) in part A | Up to 9 weeks | |
| Severity of TEAEs in part A | Up to 9 weeks | |
| Frequency of TEAEs in part B |
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Inclusion Criteria:
This applies for the time period between signing of the informed consent form and up to 90 days after the last administration of the study drug(s).
Exclusion Criteria:
Any contraindications for intake of BAY 1834845 or methotrexate, gastrointestinal, liver, renal, lung or cardiovascular disorders, malignant tumors, known severe allergies, known or suspected immunodeficiency
Medication history: drugs known to induce/inhibit liver enzymes
Smoking
Clinically relevant findings in
Known hypersensitivity to study drug(s)
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRAHealthSciences | Groningen | 9728 NZ | Netherlands |
| 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 |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000723917 | zabedosertib |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| BAY1834845 | Drug | I.v. infusion of [13C6]-labeled BAY1834845 |
|
| Methotrexate | Drug | Single dose of commercially available MTX |
|
| Up to 6 weeks |
| Severity of TEAEs in part B | Up to 6 weeks |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |