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Tracking a drug's journey: can a radioactive tracer reveal how navlimetostat leaves the body?

NCT ID NCT07777133

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase 1 study aims to understand how the body processes and eliminates navlimetostat (BMS-986504), an experimental drug. A small group of healthy female volunteers will receive a specially labeled version of the drug that can be tracked in blood, urine, and feces. By measuring drug levels and breakdown products, researchers hope to learn how the drug is absorbed, metabolized, and cleared from the body.

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), a radioactive-labeled version of the drug to track its journey through the body
What this could lead to
This study could help researchers understand how navlimetostat is absorbed, broken down, and removed from the body, which is essential for developing it as a potential treatment.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It focuses on drug processing, not on whether the drug works for any disease. Results may not predict effects in people with illness.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 have a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive. * Participants must have a recent history (ie, last month) of a minimum of 1 bowel movement per 2 days. * Participants must be female (as assigned at birth) who is an individual not of childbearing potential (INOCBP), defined as one of the following:. i) Surgically sterile (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). ii) Postmenopausal, defined as ≥ 12 consecutive months of amenorrhea in an individual over the age of 45 years (no other biological or physiological causes), and individuals \< 55 years of age with 12 months of amenorrhea must have serum FSH levels \> 40 mIU/mL at screening to confirm menopausal status. Exclusion Criteria * Participants must not have any significant acute or chronic medical illness. * Participants must not have current or recent gastrointestinal disease. * Participants must not have a history of prolonged bleeding or excessive bruising. * 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.

Healthy female participants

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Local Institution - 0001

    Madison, Wisconsin, 53704-2526, United States

  • Local Institution - 0002

    Groningen, Provincie Groningen, 9728 NZ, Netherlands

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