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

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

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

Study Overview

• Status: Completed
• Conditions: Leiomyoma
• Intervention / Treatment: Drug: Vilaprisan (BAY1002670)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein / AÖR
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • CRS Clinical-Research-Services Kiel GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Actual): July 17, 2017
• Study Completion (Actual): July 17, 2017

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: 15251; 2015-005232-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No