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

Phase 1

Completed

• Conditions: Leiomyoma
• Interventions: Drug: Vilaprisan (BAY1002670)

• Registration Number: NCT03092999
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study Start: 2017-03-28
• Study First Posted: 2017-03-28
• Status Verified: 2017-07
• Primary Completion: 2017-07-17
• Study Completion: 2017-07-17
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects with mild hepatic impairment	Vilaprisan (BAY1002670)	hepatically impaired patients (classified as Child Pugh A)
Subjects with moderate hepatic impairment	Vilaprisan (BAY1002670)	hepatically impaired patients (classified as Child Pugh B)
Healthy subjects	Vilaprisan (BAY1002670)	healthy subjects

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Frequency of Treatment Emergent Adverse Events	Up to 20 days	Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability
Changes in blood laboratory parameters	Up to 20 days	Changes in blood laboratory parameters including hematology, clotting status, serum chemistry
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 Electrocardiogram (ECG)	Up to 20 days	ECG (12-lead) after ≥10 minutes supine rest

Trial Locations

Locations (2)

Universitätsklinikum Schleswig-Holstein / AÖR; 🇩🇪 Lübeck, Germany

CRS Clinical-Research-Services Kiel GmbH; 🇩🇪 Kiel, Schleswig-Holstein, Germany