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

Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092999
• Other study ID #: 15251
• Secondary ID: 2015-005232-18
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2017
• Last updated: August 17, 2017
• Start date: March 28, 2017
• Est. completion date: July 17, 2017

Study information

• Verified date: July 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 17, 2017
• Est. primary completion date: July 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• Vilaprisan (BAY1002670)
2 mg tablet, single dose, oral administration

Locations

Country	Name	City	State
Germany	CRS Clinical-Research-Services Kiel GmbH	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Schleswig-Holstein / AÖR	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frequency of Treatment Emergent Adverse Events	Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability	Up to 20 days
Secondary	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
Secondary	Changes in blood laboratory parameters	Changes in blood laboratory parameters including hematology, clotting status, serum chemistry	Up to 20 days
Secondary	Changes in urine laboratory parameters	Changes in urine laboratory parameters including urine analysis, urine pregnancy tests	Up to 20 days
Secondary	Changes in Vital Signs	Changes in Vital Signs, including blood pressure, pulse, body temperature	Up to 20 days
Secondary	Changes in Electrocardiogram (ECG)	ECG (12-lead) after =10 minutes supine rest	Up to 20 days

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