Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to assess the effect of gemfibrozil, itraconazole and phenytoin on levels of IPN60250 in the blood of healthy adult participant.

This is an early research study, often called a Phase 1 study, looking at how the body handles a new medicine called IPN60250. Researchers want to see if other common medicines – gemfibrozil, itraconazole, and phenytoin – change how much IPN60250 stays in your blood. This is important because drug interactions can affect how well a medicine works or if it causes side effects. The study is open to healthy adults aged 18 and over, both men and women. It helps scientists understand how these drugs interact before they are given to patients with illnesses. Participants will be carefully monitored throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Ipsen Pharma

Enrolment target

Start

10 Oct 2024

Not applicable

What is this study about?

This study is a very early step in checking how a new medicine, called IPN60250, works in the human body. Think of it like a first test drive for a new car – it helps us understand the basics before it's used on the main roads.

The main goal here is to see if other common medications (gemfibrozil, which can help with cholesterol; itraconazole, an anti-fungal medicine; and phenytoin, used for seizures) change the amount of IPN60250 that stays in your blood. Our bodies process medicines in different ways, and sometimes one medicine can speed up or slow down how another medicine is broken down or removed. This can mean higher or lower levels of the new medicine than expected.

Understanding these interactions is really important for safety and for making sure a medicine works properly. If a new medicine is affected by other common drugs, doctors need to know this so they can prescribe it safely and effectively in the future, adjusting doses if necessary. This study uses healthy volunteers because it helps researchers understand the basic drug interactions without the complications of other health conditions.

Key takeaways

This is an early study testing how a new drug, IPN60250, behaves in the body.
It checks how other common medicines might interact with IPN60250.
The study needs healthy adults (18+ years old) as volunteers.
Participation involves taking medicines and having blood tests.
Your contribution helps understand new medicines for future patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome.

The study team will check your health carefully to make sure you are suitable. This is important to ensure your safety and that the study results are clear.

You won't be able to take part if you have certain health conditions or are taking specific medications that might interfere with the study or put your health at risk. The study doctors will talk to you about all the specific requirements.

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 willing to take study medicines?
Are you available for multiple clinic visits and blood tests?
Are you comfortable with the possibility of staying overnight at a clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the new medicine IPN60250, and at different times, one of the other medicines (gemfibrozil, itraconazole, or phenytoin). You will have regular check-ups, which will include blood tests to measure the levels of the medicines in your body. There will also be other tests to check your overall health and well-being. The study will involve several visits to the clinic, and you might need to stay overnight for some periods. The total length of your participation in the study, and how many visits are needed, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You won't directly benefit from taking part in this specific study, but your contribution will help researchers understand new medicines better, which could help future patients. Potential risks could include side effects from the medicines given, discomfort from blood samples, or inconvenience from the clinic visits. You will be told about all known risks before you agree to take part. Remember, you have the right to leave the study at any time, for any reason, without needing to explain why, and without 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
Germany

Common questions

What is the main goal of this study?

The main goal is to see how other common medicines affect the levels of a new drug, IPN60250, in your blood.

Who can join this study?

Healthy adults aged 18 and older, both men and women, can join.

Will I get the new medicine IPN60250?

Yes, you will be given IPN60250 and also one of the other medicines being studied.

Are there any direct benefits for me?

No, there are no direct personal benefits, but your participation helps with medical science.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, for any reason, without it affecting your medical care.