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NCT Number: NCT07544628

A Phase 1 Study of Navlimetostat Tablet Formulations

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

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

CenExel iResearch - Decatur, Decatur, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Navlimetostat

Drug

Specified dose on specified days

Other names: BMS-986504

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Up to Day 17

  2. Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to Day 17

  3. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Up to Day 17

  4. Number of participants with Adverse Events (AE)

    Time frame: Up to approximately day 37

  5. Number of participants with Serious Adverse Events (AE)

    Time frame: Up to approximately day 37

  6. Number of participants with clinically significant changes in Physical Examinations (PE)

    Time frame: Up to Day 17

  7. Number of participants with clinically significant changes in vital signs (VS)

    Time frame: Up to Day 17

  8. Number of participants with clinically significant changes in 12-lead ECGs

    Time frame: Up to Day 17

  9. Number of participants with clinically significant changes in laboratory tests results

    Time frame: Up to Day 17

Secondary outcomes

  1. Time of maximum observed drug concentration (Tmax)

    Time frame: Up to Day 17

  2. Terminal elimination half-life (T-HALF)

    Time frame: Up to Day 17

  3. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 17

  4. Apparent volume of distribution during the terminal phase (Vz/F)

    Time frame: Up to Day 17

  5. Mean residence time (MRT)

    Time frame: Up to Day 17

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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