A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
- Conditions
- Hepatic InsufficiencyDrug MetabolismLiver DiseasesPharmacokinetics
- Interventions
- Drug: Sevabertinib
- Registration Number
- NCT07102095
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Moderate Hepatic Impairment Sevabertinib Approximately 10 participants with moderate impaired hepatic function (Child-Pugh B) to achieve approximately 8 evaluable participants Arm B: Normal Hepatic Function Sevabertinib Approximately 10 matched control participants for Arm A with normal hepatic function
- Primary Outcome Measures
Name Time Method Area under plasma concentration-time curve (AUC) of sevabertinib 0-96 hours post-dose 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.
Unbound area under plasma concentration-time curve AUC (AUCu) of sevabertinib 0-96 hours post-dose 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.
Maximum observed drug concentration (Cmax) of sevabertinib in plasma 0-96 hours post-dose To assess the influence of hepatic impairment on sevabertinib exposure.
Unbound Cmax (Cmax,u) of sevabertinib in plasma 0-96 hours post-dose To assess the influence of hepatic impairment on sevabertinib exposure.
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events From signing of informed consent form (ICF) until follow-up visit (approximately 2 weeks).
Trial Locations
- Locations (2)
Clinical Pharmacology of Miami, LLC - Oncology Department
🇺🇸Miami, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Clinical Pharmacology of Miami, LLC - Oncology Department🇺🇸Miami, Florida, United States