Healthy women needed to compare two tablet versions of experimental drug
NCT ID NCT07544628
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether two different tablet forms of the drug navlimetostat are processed the same way in the body. It involves 64 healthy adult women who are not able to become pregnant. Participants will receive both tablet versions at different times to compare drug levels and safety.
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)
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 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Oct 2026
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 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.
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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 places running it
2 sites. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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CenExel iResearch - Decatur
RECRUITINGDecatur, Georgia, 30030, United States
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Local Institution - 0001
WITHDRAWNAustin, Texas, 78744, United States
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Local Institution - 0003
WITHDRAWNDecatur, Georgia, 30030, United States
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Local Institution - 0004
NOT_YET_RECRUITINGAustin, Texas, 78744, United States
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