Healthy ParticipantsPhase 1NCT07544628
A Phase 1 Study of Navlimetostat Tablet Formulations
A Phase 1 study testing Navlimetostat in people with Healthy Participants, run by Bristol-Myers Squibb at 4 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Navlimetostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Apr 2026to 2 Nov 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United States4 sites, 2 recruiting
- Withdrawn
Local Institution - 0001
Austin, Texas, 78744
- Not yet recruiting
Local Institution - 0004
Austin, Texas, 78744
Site 0004
- Recruiting
CenExel iResearch - Decatur
Decatur, Georgia, 30030
Kimball Johnson, Site 0002, 404-537-1281
- Withdrawn
Local Institution - 0003
Decatur, Georgia, 30030
About this study
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
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
- Being tested
- Navlimetostat
- Keywords
- Healthy adult female, Individuals not of childbearing potential, Open label study, Clinical Research Unit, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavlimetostatDrug
Also called BMS-986504
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: Navlimetostat |
| Treatment B | Experimental | Not described Receives: Drug: Navlimetostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measured: Up to Day 17
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to Day 17
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: Up to Day 17
Number of participants with Adverse Events (AE)
Measured: Up to approximately day 37
Number of participants with Serious Adverse Events (AE)
Measured: Up to approximately day 37
Number of participants with clinically significant changes in Physical Examinations (PE)
Measured: Up to Day 17
Number of participants with clinically significant changes in vital signs (VS)
Measured: Up to Day 17
Number of participants with clinically significant changes in 12-lead ECGs
Measured: Up to Day 17
Number of participants with clinically significant changes in laboratory tests results
Measured: Up to Day 17
Secondary outcomes (5)
Time of maximum observed drug concentration (Tmax)
Measured: Up to Day 17
Terminal elimination half-life (T-HALF)
Measured: Up to Day 17
Apparent total body clearance (CLT/F)
Measured: Up to Day 17
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: Up to Day 17
Mean residence time (MRT)
Measured: Up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start27 Apr 2026
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544628
- Sponsor's protocol ID
- CA240-0014
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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