NCT03092999

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2017

Completed
Last Updated

August 18, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

March 22, 2017

Last Update Submit

August 17, 2017

Conditions

Leiomyoma

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Frequency of Treatment Emergent Adverse Events

    Up to 20 days

  • Severity of Treatment Emergent Adverse Events

    Up to 20 days

  • Changes in blood laboratory parameters

    Up to 20 days

  • Changes in urine laboratory parameters

    Up to 20 days

  • Changes in Vital Signs

    Up to 20 days

  • +1 more secondary outcomes

Study Arms (3)

Healthy subjects

EXPERIMENTAL

healthy subjects

Drug: Vilaprisan (BAY1002670)

Subjects with mild hepatic impairment

EXPERIMENTAL

hepatically impaired patients (classified as Child Pugh A)

Drug: Vilaprisan (BAY1002670)

Subjects with moderate hepatic impairment

EXPERIMENTAL

hepatically impaired patients (classified as Child Pugh B)

Drug: Vilaprisan (BAY1002670)

Interventions

Vilaprisan (BAY1002670)DRUG

2 mg tablet, single dose, oral administration

Healthy subjectsSubjects with mild hepatic impairmentSubjects with moderate hepatic impairment

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, 23538, Germany

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

vilaprisan

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

March 28, 2017

Primary Completion

July 17, 2017

Study Completion

July 17, 2017

Last Updated

August 18, 2017

Record last verified: 2017-07

Locations

DE(2)