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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001496-23 | EudraCT Number |
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The primary objectives of this study are to investigate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1830839 | Experimental | Single Dose escalations |
|
| Placebo | Placebo Comparator | Matching Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1830839 | Drug | Dose escalation in healthy male subjects |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of BAY1830839 in plasma | AUC: area under the plasma concentration vs time curve from zero to infinity after single dose. | Day 1, 2, 3, 4, 6 ,7, 9, and 12 |
| Cmax of BAY1830839 in plasma | maximum observed drug concentration in plasma after single dose administration | Day 1, 2, 3, 4, 6 ,7, 9, and 12 |
| Frequency of treatment-emergent adverse events | From first application of study intervention up to 30 days after end of treatment | |
| Severity of treatment-emergent adverse events | From first application of study intervention up to 30 days after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13353 | Germany |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Dose escalation with safety assessment following each dose step.
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| Placebo |
| Drug |
Matching placebo |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |