Leiomyoma
Conditions
Keywords
Pharmacokinetics
Brief summary
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
Interventions
2 mg tablet, single dose, oral administration
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound) | 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 | Exposure of Vilaprisan in plasma following a single dose administration |
| Maximum observed (unbound) drug concentration (Cmax,u) | 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) in measured matrix after a single dose administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Treatment Emergent Adverse Events | Up to 20 days | Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability |
| Severity of Treatment Emergent Adverse Events | Up to 20 days | The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe |
| Changes in Vital Signs | Up to 20 days | Changes in Vital Signs, including blood pressure, pulse, body temperature |
| Changes in urine laboratory parameters | Up to 20 days | Changes in urine laboratory parameters including urine analysis, urine pregnancy tests |
| Changes in blood laboratory parameters | Up to 20 days | Changes in blood laboratory parameters including hematology, clotting status, serum chemistry |
| Changes in Electrocardiogram (ECG) | Up to 20 days | ECG (12-lead) after ≥10 minutes supine rest |
Countries
Germany
Outcome results
None listed