A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
brief summary
The goal of this study is to understand how the body processes sonrotoclax in adults with serious liver problems compared to adults with normal liver function.
detailed description
Sonrotoclax is a drug which blocks a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 helps certain blood cancer cells live and grow. By blocking Bcl-2, sonrotoclax may slow or stop cancer cell growth and help them die.
The purpose of this study is to look at the safety and blood levels of sonrotoclax in adults with serious liver problems. Results from this study will help researchers understand if dose changes are needed for adults with liver problems.
Participants will take one dose of sonrotoclax by mouth with food and remain in the clinic for about 3 days of monitoring. This study is an open-label study, meaning that both participants and study doctors will know what study drug/treatment is given.
The study will enroll approximately 12 adults in the United States (6 adults with serious liver problems and 6 adults with normal liver function).
The overall time to participate in this study is approximately 4 weeks. Participants will make regular visits to the clinic for health checks, blood tests, sonrotoclax administration and monitoring, and follow-up.
official title
A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment