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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001817-10 | EudraCT Number |
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To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).
To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1834845 | Experimental | Part 1 in healthy male subjects: Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2) |
|
| Matching Placebo | Placebo Comparator | Part 1: Matching placebo in healthy male subjects. |
|
| Chosen dose of BAY1834845 | Experimental | Part 2: This dose level will be adminstered in female and male patients with psoriasis |
|
| Placebo | Placebo Comparator | Part 2: The placebo will be adminstered in female and male patients with psoriasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1834845 | Drug | Orally administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment-emergent adverse events (TEAEs) | Part 1 in healthy male subject | Approximately 47 days |
| Severity of treatment-emergent adverse events (TEAEs) | Part 1 in healthy male subject | Approximately 47 days |
| Frequency of treatment-emergent adverse events (TEAEs) | Part 2: Patients with psoriasis | Approximately 84 days |
| Severity of treatment-emergent adverse events (TEAEs) | Part 2: Patients with psoriasis | Approximately 84 days |
| AUC(0-24)md of BAY1834845 | Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing | Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2 |
| AUC(0-12)md of BAY1834845 | Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing | Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1 |
| Cmax,md of BAY1834845 | Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing | Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1 |
| Cav,md of BAY1834845 |
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Inclusion Criteria:
Part 1 (healthy male subjects)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany | |||
| PAREXEL GmbH |
| 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 |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000723917 | zabedosertib |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Double blind
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| Matching Placebo |
| Other |
Orally administered. |
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| Midazolam | Drug | Part 1: Orally administered 1mg as a single dose. |
|
Part 1 Cav:Average concentration within a dosing interval after multiple dosing |
| Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2 |
| AUC(0-24)md of BAY1834845 | Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing | Part 2: one day between day 35 and 42 |
| AUC(0-12)md of BAY1834845 | Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing | Part 2: one day between day 35 and 42 |
| Cmax,md of BAY1834845 | Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing | Part 2: one day between day 35 and 42 |
| Cav, md of BAY1834845 | Part 2: Cav: Average concentration within a dosing interval after multiple dosing | Part 2: one day between day 35 and 42 |
| Berlin |
| 14050 |
| Germany |
| D006571 | Heterocyclic Compounds |