Tracing a new Drug's journey through the body

NCT ID NCT07712718

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This early-stage trial tracks how the experimental drug MRM-3379 moves through the body and is eliminated. Eight healthy men receive a single oral dose of a specially labeled version of the drug. Researchers measure radioactivity in blood, urine, and feces to understand absorption, distribution, metabolism, and excretion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a radiolabeled form of the experimental drug MRM-3379
What this could lead to
This study will help determine how MRM-3379 is processed by the body, which is essential for planning future trials in people with liver disease.
What could go wrong
This is a very early, small study in just 8 healthy men, so results may not predict how the drug works in patients or in women.

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 8 people

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

Started

May 2026

Expected to finish

Jul 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

Male 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: 1. Male of any race, between 18 and 55 years of age, inclusive. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a body weight between 50 and 110 kg, inclusive. 3. In good health, as determined by medical history, and as assessed by the investigator (or designee). 4. Able to comprehend and are willing to sign the ICF and abide by the trial restrictions. Exclusion Criteria: 1. History of or current medical condition that would place the participant at risk from study participation. 2. Administration of any vaccine within 30 days prior to dosing. 3. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the trial, as determined by the investigator (or designee). 4. Participation in a clinical trial involving administration of an IMP (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer. 5. Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379. 6. Participants who have previously been dosed in \>2 radiolabeled drug studies in the last 12 months. For participants who have previously been dosed in ≤2 radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the trial site where exposures are known to the investigator or 6 months prior to check-in to the trial site for a radiolabeled drug trial where exposures are not known to the investigator. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled studies must be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1. 7. Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in. 8. Participants who, in the opinion of the investigator (or designee), should not participate in this trial.

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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.

  1. The places running it

    1 site. 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

  • Fortrea Clinical Research Unit Inc

    RECRUITING

    Madison, Wisconsin, 53704, United States

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