Radioactive tracer maps where a new drug goes in the body

NCT ID NCT07814404

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

Researchers want to know how the body absorbs, breaks down, and clears an experimental oral drug called INCB161734. They give a single dose to 10 healthy men aged 19 to 55, tagging part of the drug with a tiny radioactive tracer. By measuring the tracer in blood, urine, and stool, the team can track where the drug goes and what it turns into. This kind of early study helps drug developers understand a medicine's behavior before testing it in patients.

What this could mean

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

Active substance
INCB161734, an experimental oral drug, given with a tiny radioactive tracer so researchers can follow it through the body
What this could lead to
If the drug moves through the body as expected, this could support later trials that test whether INCB161734 helps patients.
What could go wrong
This is a small, early-stage study in 10 healthy men, so it cannot show whether the drug works or is safe for patients. Results in healthy men may not apply to women, older adults, or people with disease.

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 10 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

Oct 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

19 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: * Healthy males aged 19 to 55 years (inclusive) at the time of signing the ICF. * Body mass index between 18.0 and 32.0 kg/m2 (inclusive). * Ability to swallow and retain oral medication. Exclusion Criteria: * History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. * Resting pulse \< 40 bpm or \> 100 bpm, confirmed by repeat testing at screening. * History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (QTcF interval \> 450 milliseconds \[may increase the risk associated with participating in the study or may confound ECG data analysis\], QRS interval \> 120 milliseconds, and PR interval \> 220 milliseconds). * Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis). * History of irregular bowel movements (eg, irritable bowel syndrome, frequent episodes of diarrhea, or constipation defined by less than 1 bowel movement on average per 2 days) or lactose intolerant. * History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or prostate cancer. * Current or recent (≤ 6 months of screening), clinically significant gastrointestinal disease or surgery or any history of gastrointestinal surgery (including cholecystectomy, excluding appendectomy and uncomplicated hernia repair) that is anticipated to affect the absorption of study treatment. * Any major surgery within ≤ 6 months of screening. * Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only). * Blood transfusion within 4 weeks of check-in. * Positive test for hepatitis B virus, HCV, or HIV. • Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator. * History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption \> 21 units per week (1 unit = ½ pint beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type). * Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet. * Exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or employment in a job requiring radiation exposure monitoring within 12 months prior to check-in. * History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator. * Known hypersensitivity or severe reaction to INCB161734 or any excipients of INCB161734 (refer to the IB). * Use of tobacco- or nicotine-containing products within 1 month of screening. * eGFR \< 90 mL/min/1.73 m2 based on the site's preferred formula at screening. • Note: Assessment of eGFR may be repeated once if outside of the reference range. Other protocol-defined Inclusion/Exclusion Criteria may apply.

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As listed by the trial registrant

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