Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Open label, Phase I study to assess and compare the pharmacokinetic parameters after multiple oral administration of stiripentol 1000 mg in renal impaired patients and matching controls with normal renal function

This study is designed to understand how a medicine called stiripentol behaves in the bodies of adults. Specifically, we want to see if having kidney problems changes how the body takes in, uses, and gets rid of this drug, compared to people with healthy kidneys. This is an early-stage study, meaning it's one of the first times this drug is being looked at in detail in people. The main goal is to compare how the medicine works in both groups of people after they take it by mouth several times. This information helps doctors understand the best way to use the medicine safely and effectively for different patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Biocodex

Enrolment target

Start

27 Nov 2024

Patients with renal impairement

What is this study about?

This study is about a medicine called stiripentol. Doctors want to understand how this medicine moves through the body, how quickly it's used up, and how the body gets rid of it. This process is known as 'pharmacokinetics'. It's really important because it tells doctors how much medicine to give, how often, and if adjustments are needed for certain people.

One important factor that can change how medicines work is kidney health. Our kidneys play a big role in filtering waste and medicines out of our bodies. If someone has kidney problems, their body might handle medicines differently. This study will carefully compare how stiripentol works in people who have kidney problems versus people with healthy kidneys.

By doing this, researchers can find out if kidney problems affect how the body processes stiripentol. This knowledge helps doctors make sure that if stiripentol is used in the future, it can be given safely and effectively to all patients, including those with kidney conditions. It's a foundational step to making sure medicines are right for everyone.

Key takeaways

Study focused on an existing medicine: stiripentol.
Compares how the medicine works in people with and without kidney problems.
Aims to understand how the body processes the medication.
This is an early-stage study (Phase I) for safety and basic understanding.
Participants must be adults (18 years or older).

Who may be eligible?

This study is looking for adults aged 18 and older, both men and women.

To join, you must either have a kidney condition or have healthy kidneys. The study needs both groups of people to compare how the medicine works.

There might be other specific health requirements for taking part that the study doctor will discuss with you. These are put in place to ensure your safety and the accuracy of the study results.

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?
Do you have a kidney condition, or do you have healthy kidneys?
Are you willing to take the study medicine by mouth?
Are you able to attend regular study appointments and have blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the medicine stiripentol by mouth multiple times over a period. This is an 'open label' study, which means both you and the study team will know you are receiving the active medicine. The study team will regularly take blood samples to measure how much of the medicine is in your body and how long it stays there. You would also have check-ups to monitor your general health.

The specific number of visits, tests, and the total length of your involvement will be clearly explained by the study team before you agree to participate. You will be given all the details so you know exactly what is expected.

Potential risks and benefits

Potential benefits of participating include contributing important information that could help others in the future who might need this medication, especially those with kidney conditions. As with any medicine, there are potential risks, such as side effects from stiripentol, and potential discomfort from procedures like blood tests. The study team will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Bulgaria

Common questions

What is 'stiripentol'?

Stiripentol is a medicine that doctors want to understand better, particularly how it works in the body.

What does 'kidney impairment' mean?

It means your kidneys aren't working as well as they should be, which can affect how your body handles medicines.

Why is this study important?

It helps doctors understand how to give stiripentol safely and effectively to people, especially those with kidney problems.

Will I know if I'm getting the medicine?

Yes, in this type of study, both you and the study team will know you are receiving the stiripentol medicine.

Will I have to pay to take part?

No, you should not have to pay to participate in a clinical study. Any study-related care and medication are usually provided free of charge.