Phase 1 Study to Compare Blood Levels and Food Effects of Sonrotoclax Tablet for Oral Suspension and Sonrotoclax Tablet in Healthy Adults

What this Trial Is About

Researchers are evaluating the relative bioavailability and the impact of food on the absorption of sonrotoclax, a drug given as a tablet for oral suspension, in healthy adult volunteers aged 18 to 60 years. The study aims to compare blood levels of sonrotoclax after administration of the new tablet for oral suspension with those observed using the current sonrotoclax tablet. This Phase 1, open-label, randomized crossover trial helps understand how food affects drug absorption and blood levels. Participants will receive three single oral doses on separate occasions with an 8-day washout period between each dose. The treatments include sonrotoclax tablet for oral suspension given with a high-fat meal, the same tablet after fasting, and the current sonrotoclax tablet with a high-fat meal. Each participant receives all three treatments in random order to compare drug levels under these different conditions. During the study, participants will undergo blood sampling for up to about 20 days to measure drug concentration levels, including total exposure over time and maximum concentration. Researchers will also monitor safety through assessments like vital signs, electrocardiograms, and adverse events for up to approximately 47 days. The study involves multiple visits for dosing and follow-up to ensure participant safety and collect necessary data.

A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults