NCT07544628 · Bristol-Myers Squibb
A Phase 1 Study of Navlimetostat Tablet Formulations
What this study is about
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
View original scientific description
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
Interventions
DRUG
Navlimetostat
Specified dose on specified days
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Decatur, Georgia
- Austin, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations