A Phase 1 Study of Navlimetostat Tablet Formulations

NCT07544628 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CA240-0014
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Healthy Participants

Keywords

Healthy adult female; Individuals not of childbearing potential; Open label study; Clinical Research Unit; Phase 1

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• 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

Study Arms (2)

Treatment A

EXPERIMENTAL

Drug: Navlimetostat

Treatment B

EXPERIMENTAL

Drug: Navlimetostat

Interventions

Navlimetostat DRUG

Specified dose on specified days

Also known as: BMS-986504

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description