Study of Oral Radiolabeled 14C-Bleximenib to Understand Drug Absorption and Metabolism in Adults with Acute Leukemia

What this Trial Is About

Researchers are studying how the body processes and eliminates radiolabeled bleximenib in adults with acute leukemia, a fast-growing blood cancer characterized by many immature white blood cells in the bone marrow. This Phase 1 trial aims to understand the absorption, metabolism, and excretion of this drug to inform further treatment development. Participants will receive one oral dose of radiolabeled 14C-bleximenib on the first day of treatment Cycle 1 Day 1. Starting the next day Cycle 1 Day 2, they will receive non-radiolabeled bleximenib daily until the end of the 28-day cycle. Eligible participants may then continue treatment in a related study with ongoing non-radiolabeled bleximenib. During the study, participants will undergo assessments including measurement of drug levels in urine and feces, blood concentration monitoring, and tracking of any side effects up to 58 days. Researchers will closely observe how much of the drug is excreted and how it moves through the body. The total study duration for each participant covers this initial 28-day treatment cycle and subsequent follow-up for safety and drug monitoring.

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia