Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I, open-label, fixed sequence drug interaction study in healthy subjects to investigate the effect of a 40 mg deucrictibant tablet administered once daily on the pharmacokinetics of the P-gp substrate digoxin and the BCRP substrate rosuvastatin, administered as a drug cocktail

This is an early-stage research study, called a Phase 1 study, involving healthy adults. The main goal is to see how a new medicine, called deucrictibant, interacts with two other commonly used medicines: digoxin and rosuvastatin. Participants will take deucrictibant once a day, along with a special 'cocktail' of digoxin and rosuvastatin. Researchers will carefully measure how the body processes digoxin and rosuvastatin when deucrictibant is also being taken. This helps scientists understand if deucrictibant affects how much of these other drugs get into your system and how quickly they leave. This information is important for making sure future treatments are safe and effective, especially for conditions like Hereditary Angioedema, where deucrictibant might be used.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pharvaris Netherlands B.V.

Enrolment target

Start

29 Jul 2024

Hereditary angioedema

What is this study about?

Imagine your body is like a busy factory, and medicines are products going through different machines. Some medicines might speed up or slow down how other medicines are processed. This study, called a Phase 1 study, is an early look at how a new medicine called deucrictibant interacts with other common medicines.

Researchers want to see if taking deucrictibant affects how two widely used medicines — digoxin (often used for heart conditions) and rosuvastatin (used for cholesterol) — work in your body. This is important because if deucrictibant changes how these other medicines are handled, it could affect their safety or how well they work for someone.

By understanding these interactions early on, doctors and scientists can make sure that if deucrictibant is eventually used as a treatment, for example, for Hereditary Angioedema, it can be prescribed safely alongside other necessary medicines. This study is a crucial step in developing new treatments responsibly.

Key takeaways

This is an early-stage study in healthy adults.
It investigates how a new medicine, deucrictibant, interacts with other common drugs.
Participants take deucrictibant and a combination of digoxin and rosuvastatin.
The goal is to understand how the body processes these medicines together.
It helps ensure future treatments are safe and effective.
Participation involves clinic visits, taking medication, and blood tests.

Who may be eligible?

This study is looking for healthy adults to take part. This means people who don't have any major ongoing health problems and are generally feeling well.

Anyone aged 18 years and above can be considered for this study, whether they are male or female. The study is not looking for people with a specific medical condition, as the aim is to see how the new medicine works in a healthy body.

Before you can take part, you would have a health check-up to make sure you are suitable and that participating would be safe for you.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Do you not have any major ongoing health conditions?
Are you comfortable with regular clinic visits and blood tests?
Are you able to follow study instructions carefully?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the study medicine, deucrictibant, as a tablet once a day. You would also take a mix of two other medicines, digoxin and rosuvastatin, at specific times. The study is designed to carefully measure how your body processes these medicines. This usually involves regular blood tests over a period of time to check medicine levels, as well as general health check-ups.

You would need to visit the study clinic a number of times for these assessments. The exact schedule will be explained in full detail, including how long each visit might be and what happens during it. You will be closely monitored by medical staff throughout your time in the study. After your last dose of medicine, there will be follow-up appointments to ensure you are well.

Potential risks and benefits

Like all clinical studies, there are potential risks, mainly from taking new medicines and having medical procedures like blood tests. The study team will closely monitor your health. You might experience side effects from the study medicines, which will be fully explained. The main benefit to you could be contributing to medical science, which helps develop new and safer treatments for other people in the future. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is a Phase 1 study?

Phase 1 studies are the first stage of testing a new medicine in humans, usually in healthy volunteers. They help us understand how the medicine works in the body and if it's safe.

What is Hereditary Angioedema?

Hereditary Angioedema is a rare genetic condition that causes sudden, unpredictable swelling in different parts of the body, like the face, hands, feet, or airway.

Why use healthy volunteers?

Using healthy volunteers allows researchers to understand how the new medicine acts in a body without the complexities of an existing illness, making it easier to see how it interacts with other drugs.

Will I get paid for taking part?

Compensation for your time and travel expenses is often provided in studies like this. Details would be discussed if you are considered for participation.

What is a 'drug cocktail'?

In this study, a 'drug cocktail' simply means taking a specific combination of different medicines (digoxin and rosuvastatin) at the same time to see how the new study drug affects them.