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Radioactive tag lets scientists follow an experimental drug through the human body

NCT ID NCT07812077

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers at one site in the United Kingdom are studying how the experimental drug AZD4954 is absorbed, broken down, and removed from the body. The trial enrolls 16 healthy men aged 30 to 65, split into two groups of eight. In one part, participants take a single oral liquid dose of AZD4954 tagged with a tiny amount of radioactive carbon-14 so researchers can track it in urine and stool. In the other part, participants receive a single tablet by mouth and a very small intravenous dose of the tagged drug to compare how much reaches the bloodstream by each route.

What this could mean

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

Active substance
AZD4954, an experimental drug tracked with a tiny radioactive carbon-14 label
What this could lead to
If the tracking works, researchers could better understand how AZD4954 moves through the body, which may help guide later studies of the drug.
What could go wrong
This is a small, early-stage study in 16 healthy men, so it cannot show whether the drug works for any condition. The carbon-14 label exposes participants to a very small amount of radiation, and the results may not apply to women, older adults, or people with health conditions.

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 16 people

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

Expected to start

Oct 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

30 to 65 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 30 to 65 years inclusive * BMI of 18.0 to 35.0 kg/m2 inclusive * Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: * Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients * Presence or history of clinically significant allergy requiring treatment * History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder * History of cholecystectomy or gall stones * History of GI surgery * Acute diarrhoea or constipation in the 7 days before the predicted Day 1 * Participants who do not have suitable veins for multiple venepunctures/cannulation * Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis * Evidence of renal impairment at screening * Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1 * Participants who have previously been administered IMP in this study * Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years * Participants who have been administered IMP in an ADME study in the last 12 months * Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood * Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing * Current smokers or known or suspected history of alcohol or drug abuse * Excessive intake of caffeine-containing drinks or food

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As listed by the trial registrant

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Healthy participants

How to take part

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