Active not recruitingPHASE1INTERVENTIONAL

A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144

This study in Nottingham is looking for healthy men aged 30-65 to help us understand a new medicine called AZD4144. We want to find out how it gets into the blood after being given by injection or by mouth, how the body deals with it, and if there are any side effects. To do this, the medicine will have a tiny, safe amount of carbon-14 added, which helps us track its journey through the body very precisely. This is an early-stage study to learn more about the medicine's basic behaviour in healthy people. Your participation would involve a stay at the clinic and a couple of follow-up visits.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

11 Feb 2026

Estimated completion

28 May 2026

Healthy Participants

What is this study about?

This study is a very early step in understanding a new medicine called AZD4144. Our main goal is to see how this medicine behaves in the human body. We want to find out how much of it reaches the bloodstream, how quickly it travels around, and most importantly, how the body naturally breaks it down and gets rid of it. This information is really important for deciding if the medicine should be studied further for treating specific conditions. Because it's an early study, we're testing it in healthy volunteers rather than patients.

To accurately follow the medicine's journey, we've added a tiny, harmless amount of a special carbon, called carbon-14, to the medicine. This is a common and safe way to track medicines in these types of studies. Think of it like adding a tiny, invisible tag that allows us to find and measure the medicine and its breakdown products in very small amounts within your body fluids. This helps us get a clear picture of what happens to the medicine from the moment it enters your body until it leaves.

By taking part, you would be helping researchers gather vital information about this potential new medicine. Understanding how a medicine is absorbed, distributed, metabolised (broken down), and excreted (left the body) is fundamental. This helps us ensure it's safe and effective before it can be considered for wider use, ultimately contributing to future advancements in medicine.

Key takeaways

Study is for healthy men aged 30-65 only.
Aims to understand how a new medicine works in the body.
Involves a clinic stay of up to 10 nights.
Uses a tiny, safe amount of carbon-14 to track the medicine.
Will involve blood, urine, and stool sampling.
Total study duration is up to 7 weeks.

Who may be eligible?

This study is specifically looking for healthy men aged between 30 and 65 years old. Your body weight, when measured by something called Body Mass Index (BMI), should be within a certain range (18.0 to 32.0). It's also important that you generally have regular bowel movements, meaning you usually go to the toilet for a number two between one and three times a day.

There are several reasons why you might not be able to join. For example, if you have any history of serious illnesses, especially affecting your heart, kidneys, lungs, stomach, brain, or mental health. We also can't include you if you've had a significant illness, surgery, or injury in the last month, or if you've recently had severe diarrhoea or constipation. You also need to have veins that are suitable for drawing blood multiple times. We can't include anyone who smokes, has a history of drug or alcohol abuse, or drinks too much caffeine.

Also, if you've recently been part of another clinical study, particularly if it involved a new medicine or a study that used radiation, you might not be eligible. We'll also check if you're taking any regular medicines, including herbal remedies or vitamins, as some of these can affect how our study medicine works. If you've been prescribed certain medicines or herbal remedies that affect liver enzymes in the last few weeks, you also wouldn't be able to take part.

Quick self-check

Are you a man aged between 30 and 65 years old?
Do you generally feel healthy and have no serious ongoing medical conditions?
Do you have a healthy weight for your height (BMI between 18.0 and 32.0)?
Do you have regular bowel movements (1-3 times a day usually)?
Have you avoided smoking, illegal drugs, or heavy alcohol use recently?
Have you not taken part in another clinical study involving a new drug or radiation in the last 3 months to a year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be part of a group of 8 men. You'll receive a single dose of the study medicine. This will either be given as an injection into a vein (like a drip) or as a liquid you drink by mouth. After taking the medicine, you'll stay at the clinic for up to 10 nights. During this time, the research team will closely monitor you. They will collect blood, urine, and stool samples to check your safety and how your body is handling the medicine and its breakdown products.

After your clinic stay, you'll have two more short visits to the clinic as an outpatient, meaning you won't stay overnight. These follow-up visits are important to make sure everything is still okay and to collect any final samples. The whole study process, from your first visit to your last, will take up to seven weeks. Throughout this time, the team will be checking on your health and well-being.

Potential risks and benefits

Taking part in a study like this helps us learn crucial information about new medicines, which could benefit future patients. While there isn't a direct health benefit to you as a healthy volunteer, your contribution is incredibly valuable to medical research. As with any medicine or procedure, there are potential risks. The study medicine might cause side effects, though we expect these to be mild since it's a very early-stage trial in healthy individuals. There's also the usual discomfort from blood tests and staying in a clinic. You will be fully informed of all known risks and benefits before deciding to take part, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Research Site
Ruddington, United Kingdom

Common questions

What is carbon-14 and is it safe?

Carbon-14 is a very tiny, safe amount of a special carbon that helps us track the medicine. It's too small to harm you and allows researchers to see exactly what the medicine does in the body without affecting your health.

Will I have to stay in the hospital?

Yes, you will stay in the clinic for up to 10 nights after taking the medicine. You will then have two short follow-up visits later.

What kinds of tests will I have?

You'll have regular blood, urine, and stool samples taken. These tests help us monitor your health and see how the medicine moves through and leaves your body.

Can I eat and drink normally during the study?

During your clinic stay, your diet might be controlled to ensure accurate study results. You’ll be asked to avoid excessive caffeine before and during the study.

How long will the whole study take?

From start to finish, including your clinic stay and follow-up visits, the study will take up to 7 weeks of your time.