Tiny radioactive tracer reveals Drug's journey in 5 men

NCT ID NCT06309394

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This completed Phase 1 study enrolled just 5 healthy men aged 35–55 to see how a single oral dose of the experimental drug INCB099280 (with a tiny radioactive label) is absorbed, broken down, and eliminated. Researchers measured radioactivity in urine and feces and checked drug levels in blood. The goal was purely 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
INCB099280 (a drug being tested, given as a single oral dose with a radioactive tracer)

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

5 people

The number who actually took part.

Started

May 2024

Finished

Jun 2024

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

35 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: * Ability to comprehend and willingness to sign a written ICF for the study. * Healthy males, as determined by the investigator based upon physical examinations, ECGs, vital signs, and safety laboratory assessments, aged 35 to 55 years, inclusive, at the time of signing the ICF. * Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening. * No clinically significant findings in screening evaluations (eg, clinical, laboratory, vital signs, and ECG) at screening and Day -1. * Ability to swallow and retain oral medication. Exclusion Criteria: * History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease as judged by the investigator. * History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mmHg at screening, confirmed by repeat testing). * Presence of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could possibly affect drug absorption. * Current or recent (within 6 months before screening), clinically significant, gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug. * Any major surgery within 6 months of screening. * Donation of blood to a blood bank or in a clinical study (except a screening visit) within 3 months before screening (within 2 weeks for plasma donation). * Positive test for HBV, HCV, or HIV at screening. Participants whose HBV results are compatible with prior immunization or immunity due to infection may be included at the discretion of the investigator. * Regular alcohol consumption \> 21 units per week (1 unit = 8 oz of beer or a 25-mL shot of a 40% spirit; 1.5 to 2 units = a 125-mL glass of wine, depending on type). * Positive breath test for alcohol or positive urine screen for drugs of abuse (confirmed by repeat) at screening or admission (Day -1). * Treatment with another investigational medication within 90 days or 5 half-lives (whichever is longer) before Day 1 or current enrollment in another investigational drug study. * Participation in any clinical study involving a 14C-radiolabeled investigational product within 12 months prior to admission (Day -1). * Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study. * History of tobacco- or nicotine-containing product use within 1 month before screening. Consumption of tobacco- or nicotine-containing products 72 hours before admission (Day -1) until CRU discharge is not permitted. Breath test for carbon monoxide \> 10 ppm (confirmed by repeat) at screening or admission (Day -1). * Use of prescription drugs within 14 days before Day 1 or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days before Day 1 until CRU discharge. However, paracetamol up to 4000 mg Q24H and ibuprofen up to 600 mg Q24H are permitted. Other protocol-defined 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.

Contacts and locations

Locations

  • Quotient Sciences Ltd

    Nottingham, NG11 6JS, United Kingdom

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