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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004056-38 | EudraCT Number |
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This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11) |
|
| Placebo | Placebo Comparator | Study group 1-11 of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY2328065 | Drug | Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing | Up to 8 days |
| Severity of treatment-emergent adverse events | The severity of adverse events collected from dosing until follow up, i.e. 8 days after dosing Severity is assessed by the following criteria:
| Up to 8 days |
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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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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Drug | Matching placebo, once daily in an escalating manner as LSF or tablets |
|
| D000091662 | Genital Diseases |