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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003301-17 | EudraCT Number |
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The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal (healthy subjects) | Experimental | Healthy subjects matched for age, body weight and gender to the groups with renal impairment |
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| Mildly renal impaired | Experimental | Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2 |
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| Moderately renal impaired | Experimental | Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2 |
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| Severely renal impaired | Experimental | Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulacimstat (BAY1142524) | Drug | single oral dose of 25 mg immediate-release tablet BAY1142524 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524 | AUC(0-tlast) will be used if mean AUC(tlast ∞) >20% of AUC) | Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524 | Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose | |
| AUC of unbound drug (AUCu) of BAY1142524 | AUC (0-tlast) u will be used if mean AUC (tlast ∞) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing. | Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose |
| Cmax of unbound drug (Cmax,u) of BAY1142524 | An additional blood sample for fu will be collected at 2 hours after dosing. | Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability | up to 10 days after dosing |
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Inclusion Criteria:
eGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.
Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit
- Healthy subjects eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.
Needs to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).
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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| 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 |
|---|---|
| C000709182 | fulacimstat |
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