Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn about how itraconazole affects the level of emodepside in the blood when emodepside is given as a new type of tablet to healthy participants

Researchers are conducting a study to understand how a new investigational drug called emodepside interacts with a commonly used medication called itraconazole. Emodepside is being developed as a potential treatment for certain parasitic worm infections, such as those spread through soil and river blindness. This study is a very early-stage trial, focusing on healthy volunteers. The main goal is to see how itraconazole affects the amount of emodepside in the bloodstream when both are taken together. This information helps doctors understand how to give these medicines safely and effectively if emodepside is approved in the future. It's an important step in developing new treatments for debilitating diseases.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG

Enrolment target

Start

28 Nov 2024

Soil-transmitted helminth infection Onchocerciasis (river blindness)

What is this study about?

This research study is about understanding how two medicines interact when taken at the same time. One of these medicines is called emodepside, which is a new drug being developed to treat infections caused by parasitic worms. These infections can include those spread through contaminated soil and a serious condition known as river blindness. The other medicine involved is itraconazole, which is a widely used drug for fungal infections.

Because emodepside is a new medicine, it’s important for researchers to learn as much as possible about how it behaves in the body, especially when taken with other medications. This particular study aims to find out if itraconazole changes how much emodepside gets into a person's blood. This information is crucial because it helps doctors and scientists understand if taking these two medicines together could make emodepside more or less effective, or potentially increase side effects. This is a very early stage study, meaning it's one of the first times emodepside is being tested in people.

The findings from this study will help ensure that if emodepside becomes an approved treatment in the future, doctors will know the best and safest way to prescribe it, particularly for people who might also need to take other medicines. By understanding these interactions, scientists can improve how new drugs are developed and used, ultimately helping people who suffer from these challenging worm infections.

Key takeaways

This study helps understand how a new worm medicine (emodepside) interacts with a common anti-fungal drug (itraconazole).
It's an early-stage study in healthy volunteers aged 18 and over, both men and women.
The goal is to see how itraconazole affects the amount of emodepside in the blood.
Your participation helps develop safer and more effective treatments for parasitic worm infections.
You'll have clinic visits, take study medicines, and have regular health checks like blood tests.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. To be considered, you must be at least 18 years old. There is no upper age limit for participation, meaning older adults are also welcome to inquire.

Both men and women can join this study. The researchers are looking for people who are generally healthy and not currently experiencing any serious medical conditions. This helps them understand how the medicines work in a typical body without other illnesses complicating the results.

Further checks will be done by the study team to make sure it's safe for you to take part and that you meet all the specific health requirements. This ensures the study is as safe as possible for all volunteers.

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 at least 18 years old?
Are you generally healthy, without significant long-term illnesses?
Are you comfortable visiting a clinic for regular appointments and having blood tests?
Are you willing to follow specific instructions on taking medications?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to visit the study clinic several times. During these visits, you will have various health checks, such as blood tests, to monitor how your body is reacting to the medicines. You will be given doses of both emodepside (the new investigational medicine, provided as a new type of tablet) and itraconazole (a common anti-fungal medicine). The study team will tell you exactly when and how to take these medicines.

There will be regular follow-up appointments to check on your health and collect more blood samples to measure the levels of the medicines in your system. The total duration of your participation in the study, from your first visit to your final follow-up, will be explained in detail by the study team. They will also tell you about any restrictions you might need to follow during the study, such as avoiding certain foods or other medicines.

Potential risks and benefits

Participating in this study might not directly benefit you, as a healthy volunteer, but your contribution is vital for developing new treatments that could help many people suffering from parasitic worm infections in the future. As with any medicine, there's a chance you might experience side effects from taking emodepside or itraconazole; these will be fully explained before you agree to take part. Researchers will monitor your health very closely throughout the study to identify and manage any potential issues. Remember, your participation is completely voluntary, and you are 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
Germany

Common questions

What kind of conditions is emodepside trying to treat?

Emodepside is being developed to treat parasitic worm infections, including those spread through soil and a severe eye disease called river blindness.

Why is this study only looking at healthy people?

By studying healthy people, researchers can clearly see how the medicines act in the body without other illnesses making the results complicated. This is a common and important first step for new medicines.

What is itraconazole?

Itraconazole is a medicine that is commonly used to treat infections caused by fungi.

Will I take both medicines at the same time?

Yes, a main part of this study is to see how emodepside is affected when taken with itraconazole, so you will be given both medicines at specific times as instructed by the study team.

What happens to my information after the study?

All information collected about you will be kept private and confidential. Your name will not be shared in any reports or publications from the study.