Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
2 mg tablet, single dose, oral administration
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Schleswig-Holstein / AÖR
Lübeck, Germany
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
Time frame: 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
Time frame: 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
Frequency of Treatment Emergent Adverse Events
Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability
Time frame: Up to 20 days
Severity of Treatment Emergent Adverse Events
The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe
Time frame: Up to 20 days
Changes in blood laboratory parameters
Changes in blood laboratory parameters including hematology, clotting status, serum chemistry
Time frame: Up to 20 days
Changes in urine laboratory parameters
Changes in urine laboratory parameters including urine analysis, urine pregnancy tests
Time frame: Up to 20 days
Changes in Vital Signs
Changes in Vital Signs, including blood pressure, pulse, body temperature
Time frame: Up to 20 days
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Changes in Electrocardiogram (ECG)
ECG (12-lead) after ≥10 minutes supine rest
Time frame: Up to 20 days