A Phase 1, Open-label, Randomized, 2-Treatment, 2-Period, Crossover Study to Assess the Bioequivalence of Navlimetostat Wet-Granulation Tablet Versus Dry-Granulation Tablet in Healthy Adult Female Participants Not of Childbearing Potential

What this Trial Is About

Researchers are evaluating the pharmacokinetics of Navlimetostat, comparing two tablet formulations—wet-granulation versus dry-granulation—in healthy adult females who are not of childbearing potential. This Phase 1 study aims to assess how the body absorbs and processes these two forms of the drug to understand their bioequivalence. The study is sponsored by Bristol-Myers Squibb and focuses on healthy women aged 18 to 55 years with no significant health issues. Participants will receive specified doses of Navlimetostat in a randomized, open-label, crossover design, meaning each participant will take both tablet formulations in different periods. The study includes two treatment periods where the drug is administered, with close monitoring for adverse events and clinical changes. The crossover design allows comparison within the same participants to evaluate maximum plasma concentration, drug exposure over time, and other pharmacokinetic parameters. During the study, participants undergo medical history reviews, physical exams, vital sign checks, 12-lead ECGs, and laboratory tests to monitor safety and drug effects up to approximately day 37. Researchers will measure maximum plasma concentration, area under the concentration-time curve, and assess any clinically significant changes in health status. The total participation time includes these assessments to ensure thorough evaluation of the drug's bioequivalence and safety profile.

A Phase 1 Study of Navlimetostat Tablet Formulations