RecruitingPhase 1NCT07544628

A Phase 1 Study of Navlimetostat Tablet Formulations

A Phase 1, Open-label, Randomized, 2-Treatment, 2-Period, Crossover Study to Assess the Bioequivalence of Navlimetostat Wet-Granulation Tablet Versus the Dry-Granulation Tablet Formulation in Healthy Adult Female (as Assigned at Birth) Participants Who Are Individuals Not of Childbearing Potential

Sponsor

Bristol-Myers Squibb

Enrollment

64 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participants

Summary

This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

Participants must be healthy adult INOCBP female with no clinically significant findings on medical history, PE, VS, 12-lead ECGs, or clinical laboratory determinations, as assessed by the investigator.
Participants must have BMI of 18.0 to 35.0 kg/m2.
Participants must have adequate laboratory test results for renal and hepatic function, as assessed by the investigator, defined as eGFR ≥ 90 mL/min/1.73m2 using the CKD-EPI equation (screening only), and total bilirubin, ALP, GGT, AST, ALT ≤ 1.5 × ULN.

Exclusion Criteria2

Participant must not have any significant acute or chronic medical illness (in the assessment of the investigator).
Participant must not have current or recent GI disease: Any gastrointestinal disease within 3 months of study intervention administration that could possibly affect drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure, history of pancreatitis, uncontrolled nausea or vomiting) in the opinion of the investigator.

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