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8 men take radioactive drug to track its journey through the body

NCT ID NCT07573449

Knowledge-focused Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how healthy men absorb, break down, and get rid of a drug called JNT-517. Eight men took a single dose with a radioactive tracer so scientists could track it in blood, urine, and stool. The goal was to understand the drug's path through the body, not to treat any disease.

What this could mean

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

Active substance
JNT-517 (a drug being tested)

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

8 people

The number who actually took part.

Started

Jan 2024

Finished

Feb 2025

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. Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive. 2. In good health at screening as determined by: a) Medical history, b) Physical examination, c) ECG, d) Clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable). 3. History of a minimum of 1 bowel movement per day. 4. Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions. Exclusion Criteria 1. Use or intend to use any medications/products known to alter drug absorption, metabolism and excretion processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee. 2. Alcohol consumption of \>14 units per week. 3. A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. 4. Participants having taken an investigational drug within 30 days prior to screening. 5. Participants who have previously been dosed in \>2 radiolabeled drug studies in the last 12 months. 6. Participants with exposure to significant diagnostic or therapeutic radiation (e.g. serial X-ray, computed tomography scan, barium meal). 7. Previous exposure to JNT-517. Note: Other protocol-specified inclusion/exclusion criteria may apply.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Fortrea Clinical Research Unit Inc.

    Madison, Wisconsin, 53704, United States

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