RecruitingPhase 1

A Phase 1 Study of Navlimetostat Tablet Formulations

United States64 participantsStarted 2026-04-27

Plain-language 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

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Plasma Concentration (Cmax)

Timeframe: Up to Day 17

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

Timeframe: Up to Day 17

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

Timeframe: Up to Day 17

Number of participants with Adverse Events (AE)

Timeframe: Up to approximately day 37

Number of participants with Serious Adverse Events (AE)

Timeframe: Up to approximately day 37

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

Timeframe: Up to Day 17

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

Timeframe: Up to Day 17

Trial details

NCT IDNCT07544628

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

View on ClinicalTrials.gov More Healthy Participants trials

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum Plasma Concentration (Cmax)

Timeframe: Up to Day 17

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

Timeframe: Up to Day 17

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

Timeframe: Up to Day 17

Number of participants with Adverse Events (AE)

Timeframe: Up to approximately day 37

Number of participants with Serious Adverse Events (AE)

Timeframe: Up to approximately day 37

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

Timeframe: Up to Day 17

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

Timeframe: Up to Day 17