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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001141-28 | EudraCT Number |
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To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with mild renal impairment | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
|
| Subjects with moderate renal impairment | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
|
| Subjects with severe renal impairment | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
|
| Matched healthy subject group | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1101042 | Drug | Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042 | Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042 | Study Day 1 to Study Day 6 |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042 | Maximum observed concentration of BAY1101042 in plasma after single dose administration | Study Day 1 to Study Day 6 |
| AUCu of BAY1101042 | Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042 | Study Day 1 to Study Day 6 |
| Cmax,u of BAY1101042 | Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042 | Study Day 1 to Study Day 6 |
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Inclusion Criteria:
Subjects with renal impairment:
Healthy subjects:
- eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing.
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 |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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