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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005232-18 | EudraCT Number |
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Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Experimental | healthy subjects |
|
| Subjects with mild hepatic impairment | Experimental | hepatically impaired patients (classified as Child Pugh A) |
|
| Subjects with moderate hepatic impairment | Experimental | hepatically impaired patients (classified as Child Pugh B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug | 2 mg tablet, single dose, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound) | Exposure of Vilaprisan in plasma following a single dose administration | At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days |
| Maximum observed (unbound) drug concentration (Cmax,u) | Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration | At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Treatment Emergent Adverse Events | Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability | Up to 20 days |
| Severity of Treatment Emergent Adverse Events |
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Inclusion Criteria:
For all subjects:
This is not required if safe contraception is achieved by a permanent method, such as hysterectomy, bilateral fallopian tube ligation or vasectomy.
For subjects with hepatic impairment:
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 Kiel GmbH | Kiel | Schleswig-Holstein | 24105 | Germany | ||
| Universitätsklinikum Schleswig-Holstein / AÖR |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C586669 | vilaprisan |
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The intensity of an AE is classified according to the following categories:
| Up to 20 days |
| Changes in blood laboratory parameters | Changes in blood laboratory parameters including hematology, clotting status, serum chemistry | Up to 20 days |
| Changes in urine laboratory parameters | Changes in urine laboratory parameters including urine analysis, urine pregnancy tests | Up to 20 days |
| Changes in Vital Signs | Changes in Vital Signs, including blood pressure, pulse, body temperature | Up to 20 days |
| Changes in Electrocardiogram (ECG) | ECG (12-lead) after ≥10 minutes supine rest | Up to 20 days |
| Lübeck |
| 23538 |
| Germany |