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
- Are there results?
- Not yet: the study is under way
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- Withdrawn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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07544628
- Acronym / sponsor ID
- CA240-0014
- Conditions
- Healthy Participants
- Keywords
- Healthy adult female, Individuals not of childbearing potential, Open label study, Clinical Research Unit, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Navlimetostat |
| Treatment B | Experimental | Drug: Navlimetostat |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavlimetostatAlso: BMS-986504Specified dose on specified days | Drug | Treatment A, Treatment B |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Up to Day 17
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 17
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to Day 17
Number of participants with Adverse Events (AE)
Time frame: Up to approximately day 37
Number of participants with Serious Adverse Events (AE)
Time frame: Up to approximately day 37
Number of participants with clinically significant changes in Physical Examinations (PE)
Time frame: Up to Day 17
Number of participants with clinically significant changes in vital signs (VS)
Time frame: Up to Day 17
Number of participants with clinically significant changes in 12-lead ECGs
Time frame: Up to Day 17
Number of participants with clinically significant changes in laboratory tests results
Time frame: Up to Day 17
5 secondary outcomes
Time of maximum observed drug concentration (Tmax)
Time frame: Up to Day 17
Terminal elimination half-life (T-HALF)
Time frame: Up to Day 17
Apparent total body clearance (CLT/F)
Time frame: Up to Day 17
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Up to Day 17
Mean residence time (MRT)
Time frame: Up to Day 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Navlimetostat in people with Healthy Participants, run by Bristol-Myers Squibb at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: Up to Day 17). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.