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NCT07102095 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07102095 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 18 participants.
The verdict
NCT07102095, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- DRUG Sevabertinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-07-24 |
| Est. Completion | 2025-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07102095
The ClinicalTrials.gov registry entry for NCT07102095 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sevabertinib is the first listed.
NCT07102095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07102095 about?
NCT07102095 is a clinical study titled "A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose". 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. Th...
What is the current status of trial NCT07102095?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-07-24. Estimated completion is 2025-12-03.
What interventions are being tested in trial NCT07102095?
The interventions under investigation include: Sevabertinib (DRUG).
Who is sponsoring clinical trial NCT07102095?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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