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

NCT ID: NCT03092999

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2017-07-17

Brief Summary

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

Conditions

Leiomyoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy subjects

healthy subjects

Group Type: EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type: DRUG

2 mg tablet, single dose, oral administration

Subjects with mild hepatic impairment

hepatically impaired patients (classified as Child Pugh A)

Group Type: EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type: DRUG

2 mg tablet, single dose, oral administration

Subjects with moderate hepatic impairment

hepatically impaired patients (classified as Child Pugh B)

Group Type: EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type: DRUG

2 mg tablet, single dose, oral administration

Interventions

Vilaprisan (BAY1002670)

2 mg tablet, single dose, oral administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, , Germany

Countries

Germany

Other Identifiers

2015-005232-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15251

Identifier Type: -

Identifier Source: org_study_id