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NCT07544628PHASE1RecruitingAccepts Healthy Volunteers

A Phase 1 Study of Navlimetostat Tablet Formulations

Bristol-Myers Squibb

Start Date

4/27/2026

Completion Date

10/15/2026

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 Criteria

Age Range: 18 years to 55 years

Inclusion Criteria: * 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 Criteria: * 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. * Other protocol defined inclusion/exclusion criteria applies.

Interventions

DRUG

Navlimetostat

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Conditions

Healthy Participants

Locations

CenExel iResearch - Decatur

Decatur, Georgia 30030

United States

Local Institution - 0003

Decatur, Georgia 30030

United States

Local Institution - 0001

Austin, Texas 78744

United States

Local Institution - 0004

Austin, Texas 78744

United States