Clinical trial NCT03092999: Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leiomyoma
Keywords: Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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

Primary outcomes:
measure: Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
timeFrame: 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
measure: Maximum observed (unbound) drug concentration (Cmax,u)
timeFrame: 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 outcomes:
measure: Frequency of Treatment Emergent Adverse Events
timeFrame: Up to 20 days
measure: Severity of Treatment Emergent Adverse Events
timeFrame: Up to 20 days
measure: Changes in blood laboratory parameters
timeFrame: Up to 20 days
measure: Changes in urine laboratory parameters
timeFrame: Up to 20 days
measure: Changes in Vital Signs
timeFrame: Up to 20 days
measure: Changes in Electrocardiogram (ECG)
timeFrame: Up to 20 days
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical-Research-Services Kiel GmbH
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / AÖR
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: