AuthorisedPhase II and Phase III (Integrated)Interventional

A Multicenter, Open-Label, Dose Escalation Study of the Safety, Tolerability, and Efficacy of Budiodarone for the Treatment of Subjects with Non-permanent Atrial Fibrillation

This study is investigating a new medication called Budiodarone for adults who have a common heart rhythm problem known as non-permanent atrial fibrillation (AF). This type of AF means your heart beats irregularly sometimes, but then returns to a normal rhythm on its own. The main goals are to check the medication's safety, how well people tolerate it, and if it can effectively reduce the number and length of AF episodes. Researchers will also be looking for the best dose to achieve these effects. This is an important step in finding new ways to manage AF and improve the quality of life for those affected by it. It combines two stages of research, Phase II and Phase III, to gather comprehensive information.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Xyra LLC

Enrolment target

100

Start

20 Apr 2026

Non-permanent Atrial Fibrillation

What is this study about?

This research study is about a new medication called Budiodarone, which is being tested for people who have a heart condition called non-permanent atrial fibrillation, often shortened to AF. When you have AF, the upper chambers of your heart beat irregularly instead of in a steady rhythm. In 'non-permanent' AF, these irregular heartbeats come and go, meaning your heart might go back to a normal rhythm on its own, but then the irregular beats can return. This study aims to find out if Budiodarone can help reduce how often these irregular heartbeats happen and how long they last.

The main things the researchers want to learn are: Is Budiodarone safe to use? Are there any side effects, and how well do people tolerate the medication? Does it actually help to stop or shorten episodes of AF? They'll also be looking at different doses to understand which one works best. This is really important because finding effective treatments for AF can help improve people's health and daily lives, making them feel better and potentially reducing other health risks associated with AF, like stroke.

This study is combining two phases of research, Phase II and Phase III. In Phase II, the focus is often on understanding the best dose and further checking safety. In Phase III, the medication is tested on a larger group of people to confirm its effectiveness and safety compared to existing treatments or a placebo. By combining these, researchers hope to quickly gather a lot of information to see if Budiodarone could be a valuable new treatment option for non-permanent AF.

Key takeaways

This study is testing a new medication, Budiodarone, for recurrent irregular heartbeats (non-permanent atrial fibrillation).
Its main goals are to assess its safety, how well patients tolerate it, and if it can reduce AF episodes.
The study is for adults aged 18 and over, open to all genders.
Participation involves taking the medication, regular hospital visits, physical exams, and blood tests.
You'll be closely monitored for any side effects and to see if the treatment is working.
You can withdraw from the study at any time without affecting your usual medical care.

Who may be eligible?

To join this study, participants must be adults, meaning they need to be at least 18 years old. The study is open to both men and women.

More specific details about your health and medical history would be checked by the study doctors to make sure this particular trial is safe and suitable for you. This might include information about your specific type of atrial fibrillation and any other health conditions you have.

If you are interested in taking part, the first step is always to talk to the study team. They can review your medical information and determine if you meet all the necessary criteria to be involved.

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?
Have you been diagnosed with non-permanent atrial fibrillation?
Are you able to attend regular clinic visits?
Are you comfortable potentially taking a new, experimental medication?
Are you willing to undergo various medical tests, including regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Budiodarone. The amount you take might be adjusted during the study to find the best dose for you. You would have regular visits to the study clinic where the team would check your health carefully.

These visits would involve various assessments, such as physical examinations, where a doctor checks your general health. Your vital signs, like your blood pressure and heart rate, would be measured regularly. You would also have blood tests to check things like your thyroid function and overall health. The study team would carefully monitor for any side effects and how well the treatment is working.

Throughout the study, you would be asked about your symptoms and how you are feeling. The total duration of your participation would depend on the study design, but it usually involves several months of treatment and follow-up appointments. The study team will explain the full schedule of visits and what each visit entails if you are considering joining.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new medication (Budiodarone) that might help manage your non-permanent atrial fibrillation before it's widely available. It also allows you to contribute to medical research that could help others in the future. However, there are potential risks, as with any new medication. You might experience side effects, some of which could be serious, and the treatment might not work for everyone. The study team will monitor your health very closely to identify and manage any issues. 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
Poland

Common questions

What is non-permanent atrial fibrillation?

It's a type of irregular heartbeat where the heart's upper chambers beat out of rhythm sometimes, but then usually return to a normal rhythm on their own. These episodes can come and go.

What is Budiodarone?

Budiodarone is the name of the new medication being tested in this study. Researchers want to see if it can help control irregular heartbeats in people with non-permanent atrial fibrillation.

What does a 'Phase II and Phase III Integrated Study' mean?

It means the study is combining two important stages of research. Phase II usually checks the best dose and safety, and Phase III confirms how well the medicine works and its safety in a larger group. Combining them helps speed up the research process.

Will I know if I'm getting the active drug?

While the specific wording here doesn't say, in many studies like this, participants know they are receiving the study drug (Budiodarone) because it's an 'open-label' study. The study team can give you more details about this.

What kind of regular check-ups will I have?

You'll have physical exams, vital sign measurements (like blood pressure), and regular blood tests, including checks on your thyroid function, to monitor your health and how the treatment is affecting you.