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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial to learn if itraconazole and carbamazepine affect how AZD5462 moves throughout the bodies of healthy adults

This research is a stage one study looking at how a new medicine, called AZD5462, behaves in the bodies of healthy adult volunteers. Specifically, it wants to find out if taking itraconazole (a medicine often used for fungal infections) or carbamazepine (a medicine used for epilepsy or nerve pain) at the same time changes how AZD5462 moves through and is cleared from the body. This is important information for future studies, especially for people with chronic heart failure who might need to take AZD5462 alongside other common medications. The study will help us understand potential interactions between these medicines.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
AstraZeneca AB
Enrolment target
42
Start
22 Apr 2025

What is this study about?

This study is a very early stage of research, often called a 'Phase I' study. Its main purpose is to understand how a new medicine, which we'll call AZD5462, works in the human body. We're particularly interested in how other common medicines might affect it. Imagine AZD5462 as a new car. We want to see how this car performs on its own, but also if it drives differently when you fill it with a particular type of fuel (like itraconazole, used for fungal infections) or if you add a specific additive to the engine (like carbamazepine, used for epilepsy or nerve pain).

The reason this is important is because many people, especially those with long-term conditions like chronic heart failure, often take several different medicines at once. Sometimes, one medicine can change how another medicine works in the body. It might make it more effective, less effective, or even cause unwanted side effects. By understanding these interactions early on, researchers can make sure that new medicines like AZD5462 can be given safely and effectively in the future, especially to patients who might be taking other medications.

This study isn't directly testing AZD5462 as a treatment for heart failure yet. Instead, it's gathering crucial information about its basic behaviour in healthy people. This helps us ensure that when it eventually moves to studies with patients who have heart failure, we will have a clearer picture of how it might interact with the other medicines they are already taking. It's a key step in developing new, safe, and effective treatments.

Key takeaways

  • This is an early-stage study (Phase I) for healthy adults.
  • It aims to understand how a new medicine, AZD5462, interacts with other common medications.
  • The study helps develop safer and more effective treatments for chronic heart failure patients in the future.
  • Participation involves taking medicines and having regular health checks and blood tests.
  • You will not be directly treated for any condition in this study.
  • You can stop participating at any time.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or over. This study is open to both men and women.

The researchers will also carefully check your general health to make sure you are suitable for the study. This usually involves a medical examination, blood tests, and other health checks.

Because this study is looking at how medicines interact, you will likely need to be able to stop taking certain medications for a period before and during the study. The study team will discuss all of these details with you if you are interested.

Quick self-check
  • Are you 18 years old or older?
  • Are you generally healthy?
  • Are you comfortable potentially stopping certain medications?
  • Are you available for multiple clinic visits, possibly with overnight stays?

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

What does participation involve?

If you decide to take part, you will be given AZD5462, and also either itraconazole or carbamazepine, at specific times. This will happen over a set period, likely involving several visits to a clinic, possibly including overnight stays. During these visits, the study team will regularly take blood samples to measure how much of the medicines are in your body and how they are changing over time. You might also have other tests, like checking your heart rate or blood pressure, to monitor your general health. You will be closely looked after by medical staff throughout your time in the study. The total duration of your participation, from your first screening visit to your last follow-up, will be clearly explained by the study team.

Potential risks and benefits

The main benefit of taking part in this type of study isn't directly to your own health, but you'll be helping medical science learn important information that could lead to better treatments for chronic heart failure in the future. As with any medicine, there is a possibility of side effects from AZD5462, itraconazole, or carbamazepine. The study team will explain all known potential risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Germany

Common questions

What is 'Phase I' research?

Phase I research is the very first stage of testing a new medicine in humans, usually in healthy volunteers. It focuses on how the medicine works in the body and its safety, rather than treating a disease directly.

Will this study help me with my heart failure?

No, this study is for healthy volunteers and is not designed to treat heart failure. Its purpose is to gather information about how a new medicine behaves in the body.

What is Chronic Heart Failure?

Chronic Heart Failure is a long-term condition where the heart can't pump enough blood around the body to meet its needs.

What are itraconazole and carbamazepine used for?

Itraconazole is a medicine used to treat fungal infections. Carbamazepine is used to treat epilepsy (seizures) and some types of nerve pain.

Will I be paid to take part?

Many clinical trials offer compensation for your time and travel expenses. This will be discussed in detail by the study team.

How to find out more

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

Discussion

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