account_circleRecruiting

Hepatic Insufficiency, Liver Diseases, Pharmacokinetics, Drug Metabolism

A study evaluating how moderate liver impairment affects the absorption, distribution, metabolism, and elimination of sevabertinib after a single oral dose

Trial purpose

This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).

Sevabertinib is an experimental drug being developed to treat certain types of cancers that have specific genetic changes called HER2 mutations. This includes lung cancer, tumors that have spread to other parts of the body (metastatic), and tumors that cannot be removed with surgery (unresectable). Before this medicine can be given to cancer patients with liver problems, researchers need to understand how liver disease might change the way the body handles the drug.

The study will include about 20 people divided into two groups: 10 people with moderate liver problems (called Child-Pugh B liver impairment) and 10 healthy people with normal liver function. The healthy volunteers will be matched to the liver patients by age, sex, and weight to make fair comparisons.

All participants will take a single 20 mg dose of sevabertinib by mouth and stay in the research clinic for 5 days. During this time, researchers will take blood samples at specific times to measure how much drug is in the blood and how long it stays in the body. They will also monitor participants closely for any side effects.

The main goal is to see if people with liver problems have different drug levels in their blood compared to healthy people. This information will help doctors determine if cancer patients with liver disease need different doses of sevabertinib to be safe and effective.

The study will also look at the safety and tolerability of sevabertinib in both groups. Participants will have follow-up visits to ensure their continued health and safety.

This research is important because many cancer patients also have liver problems, and understanding how liver disease affects this new cancer treatment will help ensure it can be used safely and effectively in all patients who might benefit from it.

Key Participants Requirements

Sex

All

Age

18 - 79 Years

Trial summary

Enrollment Goal
20
Trial Dates
July 2025 - January 2026
Phase
Phase 1
Could I Receive a placebo
No
Products
Sevabertinib (BAY2927088)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Recruiting
Orlando Clinical Research CenterOrlando, 32809, United States
Recruiting
Clinical Pharmacology of Miami, LLC - Oncology DepartmentMiami, 33014, United States

Primary Outcome

  • Area under plasma concentration-time curve (AUC) of sevabertinib
    To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
    date_rangeTime Frame:
    0-96 hours post-dose
  • Unbound area under plasma concentration-time curve AUC (AUCu) of sevabertinib
    To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
    date_rangeTime Frame:
    0-96 hours post-dose
  • Maximum observed drug concentration (Cmax) of sevabertinib in plasma
    To assess the influence of hepatic impairment on sevabertinib exposure.
    date_rangeTime Frame:
    0-96 hours post-dose
  • Unbound Cmax (Cmax,u) of sevabertinib in plasma
    To assess the influence of hepatic impairment on sevabertinib exposure.
    date_rangeTime Frame:
    0-96 hours post-dose

Secondary Outcome

  • Incidence and severity of adverse events
    date_rangeTime Frame:
    From signing of informed consent form (ICF) until follow-up visit (approximately 2 weeks).

Trial design

A Phase 1, open-label, single-dose study to assess the influence of hepatic impairment on the pharmacokinetics of BAY 2927088
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2