Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomised, open-label, 5-period, cross-over trial to assess the pharmacokinetics and safety of 3 oral solid formulations of buloxibutid (C21) in healthy male and female participants

We are looking for healthy adult men and women to take part in a study about a new medication called buloxibutid. This medicine is being developed to treat a serious lung condition called Idiopathic Pulmonary Fibrosis. The main aim of this study is to understand how your body takes in, uses, and gets rid of three different tablet forms of buloxibutid. We also want to check if these new forms are safe and don't cause too many side effects. This is one of the early stages of testing a new medicine in people, helping us learn more before it can potentially help patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Vicore Pharma AB

Enrolment target

Start

22 Apr 2025

Idiopahtic pulmonary fibrosis

What is this study about?

This study is about a new medicine called buloxibutid, which is being developed to help people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and stiff, making it hard to breathe. Finding new and effective treatments for IPF is very important, and that's why studies like this are carried out.

In this particular study, we're focusing on the very first steps of testing this new medicine in people. It's called a 'Phase I' study, which means we're primarily interested in how the different forms of the medicine behave in the body and if they are safe. We're not testing if it treats the illness yet; that comes much later.

We will be looking at three different ways the buloxibutid medicine could be given as a tablet. By giving these different forms to healthy volunteers, we can carefully compare how the body absorbs each one, how long it stays in the body, and how it's removed. This information is crucial for deciding which tablet form might be best to develop further for patients.

Key takeaways

This study is for healthy men and women aged 18 and over.
It tests new tablet forms of a medicine for a lung condition called IPF.
The main goals are to check safety and how the body handles the medicine.
Participation involves clinic visits and careful monitoring.
You can withdraw from the study at any time if you choose.

Who may be eligible?

To be able to join this study, you need to be a healthy adult who is at least 18 years old. There is no upper age limit for healthy volunteers in this study. Both men and women are welcome to take part.

Since this is a study for healthy people, you shouldn't have any major ongoing health problems or be taking a lot of regular medication. The researchers will have a full list of specific health checks and requirements to make sure it's safe for you to participate.

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 at least 18 years old?
Are you generally healthy with no major ongoing medical conditions?
Are you able to visit a clinic for regular appointments?
Are you comfortable having blood samples taken?
Are you able to commit to the study schedule?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive three different tablet forms of the buloxibutid medicine at different times, with breaks in between. This is known as a 'cross-over' study. You would need to visit a clinic or hospital regularly for check-ups. During these visits, doctors and nurses will take blood samples to see how the medicine is moving through your body, and they will carefully monitor your health for any side effects.

Specific details about how many visits, how long each visit lasts, and the total time you would be involved in the study would be fully explained by the study team. Usually, these types of studies involve several overnight stays or day visits over a few weeks or months. You will be closely monitored throughout the entire study period, and there will be follow-up calls or visits after your last dose of medication.

Potential risks and benefits

Taking part in this study could help scientists learn more about new medicines for Idiopathic Pulmonary Fibrosis, potentially benefiting future patients. However, there are also potential risks, such as experiencing side effects from the study medicine, which could range from mild to more serious. All known risks will be fully explained to you before you agree to take part. 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
Sweden

Common questions

What is Idiopathic Pulmonary Fibrosis?

It's a serious lung condition where the lungs become scarred and stiff, making it difficult to breathe.

Am I taking a medicine for IPF?

No, this study is in healthy volunteers to understand a new medicine, not to treat IPF yet.

Will I get paid to take part?

Many studies offer payment for your time and inconvenience, but you'd need to ask the study team for details.

What does 'Phase I' mean?

It means it's an early study in people, focusing on how safe the medicine is and how the body handles it.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your medical care.