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The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.
This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with moderately decreased renal function | Experimental | Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. |
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| Subjects with severely decreased renal function | Experimental | Subjects with severe renal impairment not on dialysis with an eGFR <30 mL/min/1.73 m*2 (CKD-EPI formula). |
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| Control subjects with normal renal function | Experimental | Subjects with an eGFR ≥90 mL/min/1.73 m*2 (CKD-EPI formula) who are matched based on sex, age, race and weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug | Single oral dose (1 x 2 mg immediate-release, film-coated tablet) |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670 | Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation [AUC(0-tlast)], if AUC cannot be estimated in all subjects. In subjects with normal and moderately reduced renal function. | -1hour (h), 30minutes (min), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1day (d), 2d, 3d, 4d, 7d, 10d, 14d |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670 | In subjects with normal and moderately reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | In subjects with normal, moderately, and severely reduced renal function. | Up to 6 weeks |
| AUC | In subjects with normal, moderately, and severely reduced renal function. |
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Inclusion Criteria:
Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis
- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR ≥90 mL/min/1.73 m*2
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D004715 | Endometriosis |
| 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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| -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| unbound AUC (AUCu) | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Cmax | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Unbound Cmax (Cmax,u) | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Apparent oral clearance (CL/F) | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Unbound CL/F (CLu/F) | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Half-life associated with the terminal slope (t1/2) | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Renal clearance (CLR) | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Fraction of free (unbound) drug in plasma (fu) | In subjects with normal, moderately, and severely reduced renal function. | -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d |
| Orlando |
| Florida |
| 32809 |
| United States |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |