NCT07544628 A Phase 1 Study of Navlimetostat Tablet Formulations
| NCT ID | NCT07544628 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2026-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2026-04-27 with a primary completion date of 2026-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07544628 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07544628 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07544628 currently recruiting?
Yes, NCT07544628 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07544628 trial being conducted?
This trial is being conducted at Decatur, United States, Decatur, United States, Austin, United States, Austin, United States.
Who is sponsoring the NCT07544628 clinical trial?
NCT07544628 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 64 participants.