check_circleStudy Completed

Leiomyoma

Bayer Identifier:

15251

ClinicalTrials.gov Identifier:

NCT03092999

EudraCT Number:

2015-005232-18

EU CT Number:

Not Available
Effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 79 Years
  • 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

  • - 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

Trial summary

Enrollment Goal
36
Trial Dates
March 2017 - July 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Kiel GmbHKiel, 24105, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany

Primary Outcome

  • 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
    date_rangeTime Frame:
    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
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    Safety Issue:
    No
  • Maximum observed (unbound) drug concentration (Cmax,u)
    Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration
    date_rangeTime Frame:
    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
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    Safety Issue:
    No

Secondary Outcome

  • Frequency of Treatment Emergent Adverse Events
    Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 20 days
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    Safety Issue:
    Yes
  • Severity of Treatment Emergent Adverse Events
    The intensity of an AE is classified according to the following categories: - Mild - Moderate - Severe
    date_rangeTime Frame:
    Up to 20 days
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    Safety Issue:
    Yes
  • Changes in blood laboratory parameters
    Changes in blood laboratory parameters including hematology, clotting status, serum chemistry
    date_rangeTime Frame:
    Up to 20 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in urine laboratory parameters
    Changes in urine laboratory parameters including urine analysis, urine pregnancy tests
    date_rangeTime Frame:
    Up to 20 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in Vital Signs
    Changes in Vital Signs, including blood pressure, pulse, body temperature
    date_rangeTime Frame:
    Up to 20 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in Electrocardiogram (ECG)
    ECG (12-lead) after ≥10 minutes supine rest
    date_rangeTime Frame:
    Up to 20 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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