Navlimetostat: how foods and other drugs affect its levels in healthy adult women
Official title: A Phase 1, Open-label, Randomized, Pharmacokinetic Study to Assess the Drug Interactions and Food Effect of Navlimetostat (BMS-986504) in Healthy Female Participants
Run by Bristol-Myers Squibb · NCT07800897 · Data updated 2026-11-12
This study tests how what you eat and certain medicines change the amount of Navlimetostat in healthy adult women.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Québec, Quebec) |
| Status | Recruiting |
| Started | August 31, 2026 |
| Main results expected | March 25, 2027 |
| Study ends | March 25, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07800897 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adult female participants (assigned at birth) who are not of childbearing potential and meet health and BMI criteria.
✕Probably not a fit
Participants with significant medical conditions or those who do not meet inclusion criteria may not receive a direct benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study explores drug–drug and food–drug interactions with Navlimetostat in healthy adult female participants. It examines how co-administration with itraconazole, rifampin, midazolam, or pantoprazole may alter Navlimetostat exposure, as well as the effect of typical meals. The study uses controlled administration and standard safety assessments to characterize pharmacokinetics and tolerability. Enrollment is limited to healthy women of non-childbearing potential who meet specific health and BMI criteria. This information helps guide dosing and labeling for future studies in broader populations.
Why it matters
Potential benefit: If successful, the findings could inform safer dosing and reduce the risk of unwanted interactions for Navlimetostat in future patient populations.
How similar studies have gone: Prior pharmacokinetic studies have shown that food and certain drugs can modify exposure for similar compounds, supporting the relevance of this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Participants must be healthy adult female (as assigned at birth) individuals not of childbearing potential (INOCBP) who have no clinically significant findings on medical history, physical examination (PE), vital signs (VS), 12-lead electrocardiograms (ECGs), or clinical laboratory determinations, as assessed by the investigator. * Participants must have a BMI of 18.0 to 35.0 kg/m2, inclusive. Exclusion Criteria * Participants must not have any significant acute or chronic medical illness (in the assessment of the investigator). * Participants must not have a history of prolonged bleeding or excessive bruising. * Participants must not have any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where it's running
-
Syneos Health Clinique; Inc.
Québec, Quebec, Canada Recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.