Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn How Different Manufactured Products of the Study Medicine Called Sisunatovir are Taken Up Into the Blood When Taken on an Empty Stomach or When Taken With a Meal in Healthy Adults

This research is investigating a new medicine named Sisunatovir, which is being developed to help people with Respiratory Syncytial Virus (RSV). RSV is a common and often mild virus, but it can be serious for some, especially young children and older adults. In this study, we want to understand how different ways of making this medicine affect how well it's absorbed into the body. We'll be giving different versions of the medicine to healthy adults, both on an empty stomach and after a meal, to see how food might change its absorption. This early-stage study is a crucial step in ensuring the medicine works as intended and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

16 Aug 2023

RSV (Respiratory Syncytial Virus)

What is this study about?

This study is about a new medicine called Sisunatovir, which could one day help people who get sick with RSV. RSV stands for Respiratory Syncytial Virus, and it’s a very common bug that usually causes cold-like symptoms, but it can be more serious for some groups, like very young babies or older people. Researchers are trying to find ways to treat RSV, and Sisunatovir is one of those potential new treatments.

In this particular study, we’re not looking at whether Sisunatovir can cure RSV or not. Instead, we’re focusing on a very important first step: understanding how the medicine gets into your body. Imagine if you eat a meal with a vitamin – sometimes the food can help your body use the vitamin better, and sometimes it doesn't make much difference. It’s the same with medicines.

So, we’re testing different types of Sisunatovir that have been made in slightly different ways. We want to see how these different versions are absorbed into the blood, both when someone has eaten recently and when their stomach is empty. This helps the scientists choose the best way to make the medicine and the best way for people to take it in the future, ensuring it works as effectively as possible.

Key takeaways

New medicine called Sisunatovir for RSV is being studied.
This study looks at how food affects medicine absorption in healthy adults.
It's an early-stage study focused on safety and how the body handles the medicine.
Participants will give blood samples and have health checks.
Participation helps scientists understand the best way to use future RSV treatments.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you need to be at least 18 years old – there's no upper age limit, as long as you're in good health. Both men and women are welcome to participate in this research.

Because this is an early-stage study about how a medicine is absorbed, we're specifically looking for people who are generally healthy. This means you shouldn't have any major ongoing health problems or be taking a lot of regular medication that might interfere with the study medicine. The research team will do medical checks to make sure it's safe for you to take part.

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 comfortable giving blood samples?
Are you able to follow specific instructions about eating before taking medicine?
Do you live in a location suitable for attending study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive different versions of the study medicine, Sisunatovir. This would happen on different occasions, sometimes after you've had a meal and sometimes when you haven't eaten for a while. The main part of your participation would involve giving blood samples regularly after taking the medicine. These samples help the researchers measure how much of the medicine is in your blood. You would also have regular health checks, like having your blood pressure taken, to make sure you're feeling well. The total duration of your involvement, including all visits and follow-up checks, would be explained fully by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main benefit here is contributing to our understanding of a new medicine that could one day help people with RSV. You would also receive medical monitoring at no cost. There might be some minor risks, such as discomfort from blood draws or potential side effects from the study medicine, though these early-stage studies are designed with safety as a top priority. Remember that 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
Belgium

Common questions

What is RSV?

RSV (Respiratory Syncytial Virus) is a common virus that usually causes mild, cold-like symptoms. It can be more serious for babies and older adults.

Will I get the RSV virus during this study?

No, this study is about how a medicine is absorbed, not about treating an RSV infection. You will not be exposed to the virus as part of this research.

What does 'Human Pharmacology (Phase I)' mean?

It means this is a very early stage of testing where researchers check a new medicine's safety and how it works in the body, often in healthy volunteers.

Will I know if I'm taking the 'empty stomach' or 'with food' version?

Yes, the study team will explain exactly when and how you need to take the medicine for each part of your participation.

Do I have to do anything special before coming to the study visits?

You might be asked to fast (not eat) for a certain number of hours before some visits, or to eat a specific meal before others. All instructions will be clearly given to you.