Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate pharmacokinetics and safety of rupatadine (10 mg) and its active metabolites in participants with hepatic impairment compared to matched control participants with normal hepatic function

This research is investigating a medicine called rupatadine, which is used to treat conditions like hives (urticaria) and hay fever (allergic rhinitis). The main goal is to understand how the body processes this medicine and its active parts, especially in people who have liver problems. Researchers will compare how rupatadine works in people with liver conditions to how it works in people with healthy livers. This early-stage study (Phase I) helps ensure that the medicine is safe and effective for patients who might have different health needs, making sure the right dose is given to everyone. It's about making sure the medicine can be used safely by a wider range of people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Noucor Health S.A.

Enrolment target

Start

01 Aug 2022

Urticaria Allergic rhinitis

What is this study about?

This study is about a medicine called rupatadine. You might have heard of it because it's used to treat common allergic reactions, like when you get itchy red spots (hives, also known as urticaria) or if you suffer from hay fever with sneezing, runny nose, and itchy eyes (allergic rhinitis).

The main aim of this research is to see how your body handles rupatadine. When you take a medicine, your body breaks it down and gets rid of it. This process is often managed by your liver. This study is particularly interested in understanding if people with liver problems process rupatadine differently compared to people whose livers are healthy. They also want to check the safety of the medicine in both groups.

By carefully studying how the medicine moves through the body and how quickly it's removed, doctors can work out the best and safest way to use rupatadine for everyone, including those with liver conditions. This is an important step to ensure that people can take their medication safely and effectively, no matter their liver health.

Key takeaways

This study investigates an allergy medicine called rupatadine.
It checks how the body processes rupatadine in people with and without liver problems.
The goal is to ensure the medicine is safe and works well for everyone.
It's an early-stage medical research study.
Participation involves taking the medicine and frequent health checks.
Both men and women aged 18 and over can potentially take part.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part.

The study is specifically looking for two groups of people: some who have liver problems and some who have healthy livers. This allows the researchers to compare how the medicine works in different situations.

Beyond age and sex, there will be other health checks to make sure the study is safe for you. The medical team will discuss all the details with you to see if you're a good fit.

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 male or female?
Do you have a pre-existing liver condition (they're looking for both people with and without)?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

This is an early-stage study, which means it's one of the first times this medicine is being looked at in detail in people. Taking part would involve some visits to a clinic where doctors will give you the rupatadine medicine. They will then take blood samples at different times to see how the medicine is processed by your body. They'll also monitor you closely for any side effects or changes in your health. There will be no long-term follow-up beyond the study period, and the total duration would be explained in full detail by the study team.

Potential risks and benefits

Participating in a study like this helps researchers learn more about how medicines work, which could benefit many patients in the future. You will receive careful medical attention throughout. However, as with any medicine, there is always a chance of experiencing side effects, although these will be closely monitored. You will be fully informed of all potential risks before deciding to take part, and you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Portugal

Common questions

What is rupatadine used for?

Rupatadine is a medicine used to treat allergies like hives (itchy red spots on the skin) and hay fever (sneezing, runny nose, and itchy eyes).

Why are liver problems important in this study?

Your liver helps process medicines in your body. This study wants to see if rupatadine works differently or needs a different dose in people with liver problems compared to those with healthy livers.

Is this a new medicine?

This study is looking at an existing medicine, rupatadine, but it's specifically focusing on how it works in people with liver conditions. It's an early-stage (Phase I) study to gather detailed safety and processing information.

Will I get the medicine if I join?

Yes, if you join, you will be given the rupatadine medicine as part of the study. The doctors will explain exactly how and when you'll take it.

Will I know if I have liver problems before joining?

The study team will perform medical checks and tests to determine your liver health as part of the screening process to see if you are suitable for the study.