Clinical trial · Interventional
Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
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
NCT03092999CI-TRIAL-00029139completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Healthy subjects
- description
- healthy subjects
- interventionNames
- Drug: Vilaprisan (BAY1002670)
- type
- EXPERIMENTAL
- label
- Subjects with mild hepatic impairment
- description
- hepatically impaired patients (classified as Child Pugh A)
- interventionNames
- Drug: Vilaprisan (BAY1002670)
- type
- EXPERIMENTAL
- label
- Subjects with moderate hepatic impairment
- description
- hepatically impaired patients (classified as Child Pugh B)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.