Phase 1 Study Comparing Navlimetostat Wet-Granulation and Dry-Granulation Tablet Forms in Healthy Adult Women Not of Childbearing Potential

What this Trial Is About

This trial studies healthy adult females not of childbearing potential, aiming to compare how Navlimetostat behaves in the body after taking two different tablet formulations a wet-granulation tablet and a dry-granulation tablet. The purpose is to assess the bioequivalence of these formulations, meaning whether they deliver the drug similarly. The study is a Phase 1, open-label, randomized crossover trial sponsored by Bristol-Myers Squibb. Participants will receive two treatments the wet-granulation and dry-granulation tablets of Navlimetostat, given in two separate periods. The study uses a crossover design where participants receive both treatments in a random order, allowing comparison within the same individual. Dosing occurs on specified days, and the study monitors pharmacokinetic parameters up to 17 days after dosing. During the study, participants will undergo evaluations including blood sampling to measure drug levels, physical examinations, vital signs, ECGs, and lab tests to monitor safety and effects. Researchers will track adverse events up to about 37 days. The main outcomes include peak drug concentration and overall drug exposure, with additional measures of drug clearance and half-life. The trial lasts until about 37 days after dosing, with ongoing safety monitoring.

A Phase 1 Study of Navlimetostat Tablet Formulations