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

Bayer

Status and phase: Completed; Phase 1

Conditions: Leiomyoma

Treatments: Drug: Vilaprisan (BAY1002670)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03092999

2015-005232-18 (EudraCT Number)

15251

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Healthy subjects

Experimental group

Description:

healthy subjects

Treatment:

Drug: Vilaprisan (BAY1002670)

Subjects with mild hepatic impairment

Experimental group

Description:

hepatically impaired patients (classified as Child Pugh A)

Treatment:

Drug: Vilaprisan (BAY1002670)

Subjects with moderate hepatic impairment

Experimental group

Description:

hepatically impaired patients (classified as Child Pugh B)

Treatment:

Drug: Vilaprisan (BAY1002670)