Back to resultsEffect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
Primary Purpose
Leiomyoma
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Vilaprisan (BAY1002670)
Sponsored by
About this trial
This is an interventional other trial for Leiomyoma focused on measuring Pharmacokinetics
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
Sites / Locations
- CRS Clinical-Research-Services Kiel GmbH
- Universitätsklinikum Schleswig-Holstein / AÖR
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy subjects
Subjects with mild hepatic impairment
Subjects with moderate hepatic impairment
Arm Description
healthy subjects
hepatically impaired patients (classified as Child Pugh A)
hepatically impaired patients (classified as Child Pugh B)
Outcomes
Primary Outcome Measures
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
Maximum observed (unbound) drug concentration (Cmax,u)
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration
Secondary Outcome Measures
Frequency of Treatment Emergent Adverse Events
Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability
Severity of Treatment Emergent Adverse Events
The intensity of an AE is classified according to the following categories:
Mild
Moderate
Severe
Changes in blood laboratory parameters
Changes in blood laboratory parameters including hematology, clotting status, serum chemistry
Changes in urine laboratory parameters
Changes in urine laboratory parameters including urine analysis, urine pregnancy tests
Changes in Vital Signs
Changes in Vital Signs, including blood pressure, pulse, body temperature
Changes in Electrocardiogram (ECG)
ECG (12-lead) after ≥10 minutes supine rest
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03092999
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
July 17, 2017 (Actual)
Study Completion Date
July 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma
Keywords
Pharmacokinetics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
healthy subjects
Arm Title
Subjects with mild hepatic impairment
Arm Type
Experimental
Arm Description
hepatically impaired patients (classified as Child Pugh A)
Arm Title
Subjects with moderate hepatic impairment
Arm Type
Experimental
Arm Description
hepatically impaired patients (classified as Child Pugh B)
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg tablet, single dose, oral administration
Primary Outcome Measure Information:
Title
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
Description
Exposure of Vilaprisan in plasma following a single dose administration
Time 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
Title
Maximum observed (unbound) drug concentration (Cmax,u)
Description
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration
Time 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
Secondary Outcome Measure Information:
Title
Frequency of Treatment Emergent Adverse Events
Description
Frequency of Treatment Emergent Adverse Events as a measure of safety and tolerability
Time Frame
Up to 20 days
Title
Severity of Treatment Emergent Adverse Events
Description
The intensity of an AE is classified according to the following categories:
Mild
Moderate
Severe
Time Frame
Up to 20 days
Title
Changes in blood laboratory parameters
Description
Changes in blood laboratory parameters including hematology, clotting status, serum chemistry
Time Frame
Up to 20 days
Title
Changes in urine laboratory parameters
Description
Changes in urine laboratory parameters including urine analysis, urine pregnancy tests
Time Frame
Up to 20 days
Title
Changes in Vital Signs
Description
Changes in Vital Signs, including blood pressure, pulse, body temperature
Time Frame
Up to 20 days
Title
Changes in Electrocardiogram (ECG)
Description
ECG (12-lead) after ≥10 minutes supine rest
Time Frame
Up to 20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
CRS Clinical-Research-Services Kiel GmbH
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein / AÖR
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
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Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
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