Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Clinical Study to Compare the Impact of Multiple-dose Oral Administration of Macitentan, 10 mg versus 75 mg on Endothelin-1 Clearance, Endothelial Function, and Hemodynamics in Healthy Participants

This study is investigating a medicine called macitentan, which is already used to treat a serious lung condition called pulmonary arterial hypertension. In this particular study, healthy volunteers will be given either a 10 mg or 75 mg dose of macitentan. The main goal is to understand how these different doses affect certain natural body processes related to blood vessels and blood flow. Researchers will specifically look at how the drug impacts a substance called Endothelin-1, how well blood vessels are working, and changes in blood pressure and flow. This early-stage study helps scientists learn more about new medicines before they are tested in people who are unwell.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Actelion Pharmaceuticals Ltd.

Enrolment target

Start

05 Feb 2024

Pulmonary Arterial Hypertension

What is this study about?

This study is all about a medicine called macitentan. It's already approved and used to treat a difficult lung condition called pulmonary arterial hypertension. This condition makes blood vessels in the lungs narrower, meaning the heart has to work much harder to pump blood through them.

However, before a medicine is given to people with a condition, sometimes doctors and scientists need to understand more about how it works in healthy people. This helps them learn more about the drug's basic effects. In this study, healthy volunteers will receive either a standard dose (10 milligrams) or a higher dose (75 milligrams) of macitentan.

The main aim is to see how these doses affect certain natural processes in the body, particularly those related to blood vessels and blood flow. They will look at things like a natural chemical called Endothelin-1, which can affect blood vessel narrowing, and how well blood vessels are working overall. This kind of early research is really important for building a full picture of how a medicine works.

Key takeaways

This is an early-stage study of a lung medicine called macitentan.
It involves healthy adult volunteers, both men and women.
The study aims to understand how different doses of the medicine affect blood vessels and blood flow.
It helps researchers learn more about how macitentan works in the body.
Participation involves taking the medicine and attending clinic visits for tests.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Because this study is looking at how the medicine works in healthy people, you would generally need to be in good health. This means you shouldn't have any serious ongoing medical conditions or be taking medicines that might interfere with the study drug.

The research team will carry out some checks to make sure the study is right for you and that you meet all the health requirements to take part safely.

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 appointments?
Are you willing to take a study medicine by mouth?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine (macitentan) by mouth, likely as a tablet. You would either get a 10 mg dose or a 75 mg dose. This would happen over several days, as it's a 'multiple-dose' study. You would need to visit the study clinic regularly for appointments.

During these visits, the research team would do various checks. This might include giving blood samples, checking your blood pressure and heart rate, and possibly doing other tests to see how your blood vessels are working. You would be carefully monitored throughout the study to ensure your safety. The total duration of your involvement in the study would be explained to you in detail by the research team.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. For healthy volunteers, a direct medical benefit is unlikely as you don't have the condition being treated. However, you would contribute valuable information to medical science, which could help future patients. Potential risks might include side effects from the study medicine, which could range from mild (like a headache or feeling tired) to more serious, though serious side effects are carefully monitored for and are generally rare in these types of studies. You would be fully informed of all known and potential risks before deciding to join, and you are always free 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
France

Common questions

What is pulmonary arterial hypertension?

It's a serious lung condition where blood vessels in the lungs become narrow, making it hard for the heart to pump blood through them.

What is macitentan?

It's a medicine approved to treat pulmonary arterial hypertension by helping to relax and widen these blood vessels.

Why are healthy people needed for this study?

Studying healthy people helps researchers understand how a medicine works in the body before it's tested more widely in people who are unwell.

Will I get paid for taking part?

This information is not provided here, but compensation for your time and travel is often offered in medical studies and would be discussed with you.

How long will the study last for me?

The exact duration for each participant would be explained by the study team, as this information is not detailed in the summary given.