Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)

Study Overview
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Brief Summary
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Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)

Official Title
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Investigation of Pharmacokinetics, Safety, and Tolerability of Vilaprisan (BAY1002670) in Subjects With Hepatic Impairment (Classified as Child-Pugh A or B) Compared to Sex, Age, and Weight-matched Healthy Subjects Following a Single Oral Dose

Conditions
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Leiomyoma

Intervention / Treatment
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* Drug: Vilaprisan (BAY1002670)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For all subjects: The informed consent must be signed before any study specific tests or procedures are done White/Caucasian men and women aged between 18 to 79 years (inclusive ) Body mass index (BMI): 18 to 34 kg/m2 (both inclusive) Ability to understand and follow study-related instructions Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and three months after administration of study drug. Subjects must agree to use two non-hormonal methods for contraception simultaneously (e.g. condom or diaphragm, plus spermicide) throughout the study when sexually active. 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: Subjects with documented liver cirrhosis confirmed by histopathology, laparoscopy, fibroscan, or ultrasound Subjects with hepatic impairment (Child-Pugh A or B) Subjects with stable liver disease, i.e. same Child-Pugh class in the last 2 months Exclusion Criteria: Any relevant disease within 4 weeks prior to study drug administration requiring medical treatment Known severe allergies, non-allergic drug reactions, or multiple drug allergies Use containing sex hormones within 4 weeks to six months before first study drug administration Use of CYP3A4 and P-glycoprotein inhibitors or inducers Use of drugs which may affect absorption Major change of medication <2 weeks prior study drug administration Deviations from normal range in physical examination, gynecological examination, clinical chemistry, hematology, or urinalysis considered to be relevant by the investigator Any criteria which, in the opinion of the investigator, make study participation unadvisable for scientific, compliance, safety, or medical reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br>healthy subjects | Drug: Vilaprisan (BAY1002670)<br>* 2 mg tablet, single dose, oral administration<br>|
| Experimental: Subjects with mild hepatic impairment<br>hepatically impaired patients (classified as Child Pugh A) | Drug: Vilaprisan (BAY1002670)<br>* 2 mg tablet, single dose, oral administration<br>|
| Experimental: Subjects with moderate hepatic impairment<br>hepatically impaired patients (classified as Child Pugh B) | Drug: Vilaprisan (BAY1002670)<br>* 2 mg tablet, single dose, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | The intensity of an AE is classified according to the following categories: Mild Moderate Severe | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics