Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial to learn how baxdrostat affects the heartbeat in healthy participants

Researchers are conducting a study to understand how a new medicine, baxdrostat, might affect the way your heart beats. This is a very early stage study, sometimes called Phase 1, which means it’s primarily for healthy adults. The main goal is to check how the medicine works in the body and if it has any unexpected effects on your heart. While baxdrostat is eventually intended for people with high blood pressure that's hard to control, this specific study is about gathering basic safety and heart rhythm information first. Your participation could help researchers learn more about this potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Astrazeneca AB

Enrolment target

Start

30 Jan 2024

Treatment-resistant hypertension Primary aldosteronism Uncontrolled hypertension

What is this study about?

This research study is about a new medicine called baxdrostat. The main purpose of this study is to carefully look at how this medicine affects your heart's electrical activity, which controls your heartbeat. Researchers want to make sure it doesn't cause any unexpected changes to your heart rhythm. This is a very early stage of testing for a new medicine, sometimes called Phase 1, which means it's about understanding how the medicine works in the body and if it's safe at different doses.

Even though this medicine is being developed to help people with high blood pressure that is difficult to manage or a condition called primary aldosteronism (where your body makes too much of a certain hormone that raises blood pressure), this particular study is enrolling healthy volunteers. This is standard practice for new medicines – they are often first tested in healthy people to understand their basic effects and safety before being given to people with the conditions they are meant to treat.

Your involvement in this study, as a healthy volunteer, is really important. It helps scientists gather crucial information about how baxdrostat works in the human body. The knowledge gained from this study will help decide if the medicine can move on to later stages of testing with people who have the target conditions, bringing us closer to potentially new ways to manage high blood pressure.

Key takeaways

This study is testing a new medicine called baxdrostat.
It aims to understand how the medicine affects heartbeats in healthy adults.
This is an early-stage study (Phase 1) to check safety and basic effects.
Your participation helps advance research for conditions like high blood pressure.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. You need to be generally healthy to take part in this research.

Because this is an early study looking at a new medicine, there will be specific health requirements. For example, you likely shouldn't have any major ongoing health problems, especially those affecting your heart or other key organs. The research team will do a thorough health check to make sure participating is safe for you.

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 18 years old or older?
Are you generally in good health?
Are you able to attend several clinic visits?
Are you comfortable taking a new, experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, baxdrostat, for a period of time. You would have several visits to the study clinic, where doctors and nurses would perform various checks. These checks would likely include regular electrocardiograms (ECGs) to monitor your heart rhythm, blood tests, and measurements of your blood pressure and heart rate. You would also have follow-up visits after you stop taking the medicine to ensure you are well. The total duration of your involvement could range from several weeks to a few months, including screening, dosing, and follow-up periods.

Potential risks and benefits

Potential benefits could include contributing to medical research and helping doctors learn more about new treatments for high blood pressure. As this is a new medicine, there might be unknown side effects, and some common side effects could include feeling tired, headaches, or stomach upset. There's also a small risk of developing a serious side effect. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is 'Phase 1' of a clinical trial?

Phase 1 is the first stage where a new medicine is tested in people. It typically involves a small group of healthy volunteers and aims to find out if the medicine is safe, what dose is best, and how it acts in the body.

Is this medicine for high blood pressure?

Eventually, yes, baxdrostat is being developed for people with hard-to-treat high blood pressure. However, this specific study is first testing it in healthy people to understand its basic effects, especially on the heart.

Will I get paid to take part?

Some studies offer payment for your time, travel, and inconvenience. This would be clearly explained by the research team if you are eligible.

What happens if I change my mind?

You are free to stop participating in the study at any time, for any reason, without it affecting your current or future medical care. You just need to let the study team know.

What is an ECG and why would I need one?

An ECG (electrocardiogram) is a simple, painless test that records the electrical activity of your heart. It’s used in this study to carefully monitor how the new medicine might affect your heart's rhythm.