Can food or other drugs change how navlimetostat acts in the body?
NCT ID NCT07800897
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 1 trial enrolls healthy adult women to measure how an experimental drug called navlimetostat behaves when taken with a high-fat meal or with other medications like itraconazole, rifampin, midazolam, and pantoprazole. Researchers will track drug levels in the blood and monitor for side effects. The goal is to understand whether food or common drugs alter navlimetostat's absorption or breakdown, which guides future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- navlimetostat (BMS-986504), an experimental drug, given alone or with itraconazole, rifampin, midazolam, or pantoprazole, and with or without a high-fat meal
- What this could lead to
- If successful, this study could help determine safe dosing and potential drug interactions for future trials of navlimetostat in patients.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients, so it won't show whether the drug works for any disease. Results may not predict effects in people with illnesses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.