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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Navlimetostat

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • CenExel iResearch - Decatur
      • Contact: Kimball Johnson, Site 0002; Phone Number: 404-537-1281
    • Decatur, Georgia, United States, 30030
      • Not yet recruiting
      • Local Institution - 0003
      • Contact: Site 0003
  • Texas
    • Austin, Texas, United States, 78744
      • Recruiting
      • PPD
      • Contact: Sabrina Merchant, Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment B	Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504
Experimental: Treatment A	Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax)	Up to Day 17
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	Up to Day 17
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Up to Day 17
Number of participants with Adverse Events (AE)	Up to approximately day 37
Number of participants with Serious Adverse Events (AE)	Up to approximately day 37
Number of participants with clinically significant changes in Physical Examinations (PE)	Up to Day 17
Number of participants with clinically significant changes in vital signs (VS)	Up to Day 17
Number of participants with clinically significant changes in 12-lead ECGs	Up to Day 17
Number of participants with clinically significant changes in laboratory tests results	Up to Day 17

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of maximum observed drug concentration (Tmax)	Up to Day 17
Terminal elimination half-life (T-HALF)	Up to Day 17
Apparent total body clearance (CLT/F)	Up to Day 17
Apparent volume of distribution during the terminal phase (Vz/F)	Up to Day 17
Mean residence time (MRT)	Up to Day 17

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; Open label study; Healthy adult female; Individuals not of childbearing potential; Clinical Research Unit
• Other Study ID Numbers: CA240-0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No