RecruitingPHASE1INTERVENTIONAL

Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants

This research study is for healthy volunteers and aims to understand how a new medicine, AZD4144, behaves in the human body. We're specifically interested in its 'pharmacokinetics' – that's how the body absorbs, distributes, breaks down, and removes the medicine. The study will look at AZD4144 on its own, and also how it acts when taken with another common medicine called itraconazole. Understanding these interactions is very important for knowing how to use AZD4144 safely and effectively if it becomes a treatment in the future. This is an early-stage study (Phase 1) to gather essential safety and dosage information.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

30 Jul 2026

Estimated completion

29 Oct 2026

Healthy

What is this study about?

This study is looking into a new medicine called AZD4144. It's a very early-stage study, meaning we're gathering basic information on how it works in the body before it can be tested in people with specific illnesses. Think of it like learning how a car handles on a test track before it goes on the main roads. For this study, we're inviting healthy volunteers to help us understand something called 'pharmacokinetics'. This fancy word simply means how the body handles the medicine – how it gets into your system, where it goes, how long it stays, and how it eventually leaves your body.

Specifically, we want to know if another medicine, itraconazole, changes how AZD4144 behaves. Itraconazole is a medicine sometimes used to treat fungal infections. When two medicines are taken together, sometimes one can affect how the other works in the body. It could make the other medicine stronger, weaker, or stay in the body for a different amount of time. Understanding these potential interactions is crucial for patient safety.

By carefully studying how AZD4144 works alone and with itraconazole, researchers can learn important details about its safety and how it should be given. This information is vital for deciding the right dose and for understanding if there are any medicines that shouldn't be taken with AZD4144 in the future. This helps pave the way for potential new treatments.

Key takeaways

This study helps understand how a new medicine (AZD4144) works in the body.
It also checks if another medicine (itraconazole) changes how AZD4144 behaves.
Only healthy volunteers aged 18-55 can participate.
Participation involves health checks, taking medicines, blood samples, and follow-up visits.
No direct health benefit, but helps future medicine development.
You can leave the study at any time.

Who may be eligible?

To be part of this study, you need to be a healthy person between 18 and 55 years old. You should have good veins that are suitable for taking blood samples or having a drip inserted. Your body mass index (BMI) – a measure of weight in relation to height – should be between 18 and 30, and you must weigh at least 50 kilograms.

If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the study and agree to use highly effective birth control throughout the study and for a period afterwards. Men must also agree to use adequate birth control and not donate sperm during the study and for a specified time after the last dose.

There are also some reasons you wouldn't be able to join. For example, if you have any serious or long-term health problems, a history of certain digestive, liver, or kidney conditions, or if you have an active infection. You also can't participate if you have a known allergy to AZD4144 or itraconazole, or if routine health checks (like a heart trace or blood tests) show anything unusual that could affect the study results. You also cannot be taking medicines that affect your immune system (immunosuppressants) or steroid treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Do you generally feel healthy with no serious long-term medical conditions?
Do you have a Body Mass Index (BMI) between 18 and 30, and weigh at least 50 kg?
Are you able and willing to use effective contraception if you are a man or a woman who could become pregnant?
Do you have suitable veins for blood tests or a drip?
Are you free from allergies to AZD4144 or itraconazole?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a 'screening' visit, which can last up to 28 days. During this time, we'll check your general health to make sure you're suitable for the study. This will involve physical examinations, blood tests, and other health checks.

Once accepted, you'll then go through three treatment periods. During these periods, you'll receive AZD4144 on its own, itraconazole on its own, and then AZD4144 together with itraconazole. You'll either receive AZD4144 as a drink or as a drip into your arm (intravenous infusion). The study is 'open-label', which means both you and the study staff will know which medicine you're taking. You'll be randomly assigned to one of two groups.

Throughout these treatment periods, the study team will take blood samples regularly to measure how the medicines are moving through your body. There will also be other checks to monitor your health and safety. After the treatment periods are finished, you will have one final follow-up visit to ensure you are well. The total duration of your involvement, from screening to the final visit, will be explained in detail.

Potential risks and benefits

Participating in this study might not offer a direct health benefit to you as a healthy volunteer, but the information gained is very important for future medical research and could help develop new medicines for others. Like all medicines, AZD4144 and itraconazole can have side effects. The study team will explain all known or potential risks in detail before you decide to join. Your safety and well-being are our top priority, and you will be closely monitored throughout the study. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Research Site
Verified postcode
Harrow, United Kingdom· Recruiting

Common questions

What does 'pharmacokinetics' mean?

It's a way of describing how your body handles a medicine – how it's absorbed, moves around, is broken down, and eventually leaves your system.

Why is this study only for 'healthy participants'?

By studying healthy people, researchers can understand how the medicine works in a typical body without other health conditions affecting the results. This is common in early-stage trials.

What is itraconazole?

Itraconazole is an existing medicine that doctors sometimes prescribe to treat certain fungal infections.

Will I know which medicine I'm taking?

Yes, this is an 'open-label' study, meaning both you and the study team will know which medicines you are receiving.

How long will I be involved in the study?

Your involvement, including health checks before treatment, the treatment periods, and a final check-up, will be explained in detail by the study team.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.