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Comparing Navlimetostat Tablet Formulations in Healthy Women

This study is testing two different tablet forms of a drug called Navlimetostat in healthy women. The goal is to see how the body absorbs and processes each tablet form. Researchers will measure the amount of Navlimetostat in your blood over time to understand these differences. You can join if you are a healthy woman between 18 and 55 years old with a healthy body mass index (BMI) and normal kidney and liver function. This study is looking for 64 participants. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 64 healthy female participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Blood levels of Navlimetostat will be measured for up to 17 days after administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07544628

A Phase 1 Study of Navlimetostat Tablet Formulations

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Bristol-Myers Squibb
~64 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Navlimetostat

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Plasma Concentration (Cmax)
Measured over Up to Day 17
+8 more outcomes measured

Conditions

Healthy Participants

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Healthy Volunteers

NCT07544628

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • CenExel iResearch - Decatur

    Decatur, Georgiastudy coordinator listed

    Recruiting

  • Local Institution - 0004

    Austin, Texasno site contact published

    Not yet recruiting

  • Local Institution - 0001

    Austin, Texasno site contact published

    Withdrawn

  • Local Institution - 0003

    Decatur, Georgiano site contact published

    Withdrawn

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 ECGsUp to Day 17
  • Number of participants with clinically significant changes in laboratory tests resultsUp to Day 17