Navlimetostat: a first-in-human look at two tablet formats in healthy adults
Official 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
Run by Bristol-Myers Squibb · NCT07544628 · Data updated 2026-11-12
This early-phase study tests whether two tablet formulations of Navlimetostat behave similarly in healthy adult women who aren’t of childbearing potential.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 64 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 4 sites (Decatur, Georgia and 3 other locations) |
| Status | Recruiting |
| Started | April 27, 2026 |
| Main results expected | November 2, 2026 |
| Study ends | November 2, 2026 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07544628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adult females who are not of childbearing potential, have BMI 18.0–35.0 kg/m2, and normal renal/hepatic function.
✕Probably not a fit
Participants with significant medical conditions or abnormal organ function, or those who are unable to comply with study procedures, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, open-label trial compares the pharmacokinetics of Navlimetostat after taking a wet-granulation tablet versus a dry-granulation tablet in healthy adult female volunteers. Participants will be screened for good health, kidney and liver function, and body mass index, and will receive the drug under controlled conditions at two study sites in Decatur, GA and Austin, TX. The study design focuses on absorption, distribution, metabolism, and excretion to understand how formulation aspects influence drug exposure. Safety monitoring and laboratory assessments will accompany dosing to identify any initial tolerability issues. No disease treatment is being tested in this healthy population.
Why it matters
Potential benefit: If successful, results could inform the most appropriate tablet formulation for consistent drug exposure in future patient studies.
How similar studies have gone: Prior phase 1 work often shows formulation differences can affect absorption, making this approach common but not universally proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
CenExel iResearch - Decatur
Decatur, Georgia, United States Recruiting -
Local Institution - 0003
Decatur, Georgia, United States Withdrawn -
Local Institution - 0001
Austin, Texas, United States Withdrawn -
Local Institution - 0004
Austin, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.