Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn about how much emodepside gets absorbed in the blood and how food affects its absorption when given as a new type of tablet to healthy participants

This research is looking at a new tablet version of a medicine called emodepside. Emodepside is currently used in animals, but scientists want to see if it can help people with certain parasitic worm infections, like river blindness (onchocerciasis) and soil-transmitted worms. The main goal of this particular study is to understand how well the medicine is absorbed into the bloodstream when taken as a new tablet. They also want to find out if eating food before or after taking the tablet changes how the body absorbs it. This study involves healthy volunteers and is an early step in developing this medicine for human use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer AG

Enrolment target

Start

01 Mar 2024

Onchocerciasis (river blindness): is an infectious disease caused by Onchocerca volvulus a parasitic nematode worm. The disease is contracted through the bite of an infected blackfly of the genus Simulium which transmits third-stage infective larvae. An estimated 18 million people suffer from onchocerciasis with 99% cases in 31 African countries and 187 million people at risk Onchocercal dermatitis is the most common symptom of the disease but severe visual impairment and blindness are the most severe complication they require patients to be given treatment (ivermectin) at regular intervals for the life of the adult worm (up to 15 years)making implementation extremely difficult in endemic countries. Emodepside is a registered drug for animal health marketed by Bayer Animal Health GmbH under the name of Profender® (in combination with praziquantel) or Procox® (in combination with toltrazuril). It is a cyclooctadepsipeptide anthelmintic drug.Soil-transmitted helminth infection: Soil-transmitted helminthiasis is caused by one of the three soil-transmitted helminths (STH)Ascaris lumbricoides Trichuris trichiura and hookworm (Ancylostoma duodenale and Necator americanus). Currently STH still infects about 1.5 billion people worldwide mostly in tropical and subtropical regions. Emodepside is a registered drug for animal health marketed by Bayer Animal Health GmbH under the name of Profender® (in combination with praziquantel) or Procox® (in combination with toltrazuril). It is a cyclooctadepsipeptide anthelmintic drug.

What is this study about?

This study is looking into a medicine called emodepside, which is currently used to treat worms in animals. Scientists are now exploring if it could be a useful new treatment for humans, particularly for two serious parasitic worm infections: river blindness (onchocerciasis) and soil-transmitted worm infections.

River blindness is a disease caused by a tiny parasitic worm spread by infected blackflies. It affects millions of people, mostly in Africa, and can lead to severe skin problems and even permanent blindness. While there are treatments available, they often need to be taken for many years, which can be very difficult for patients. Soil-transmitted worm infections are also very common worldwide, especially in warmer climates, affecting about 1.5 billion people. These infections can cause various health problems, especially in children.

Because emodepside works well in animals, researchers hope it could offer a new and potentially easier-to-use treatment for people. This study is a very early step, focusing on how the medicine interacts with the human body. Researchers will be giving healthy volunteers a new tablet form of emodepside to see how much of it reaches the bloodstream and if food affects this process. This information is crucial for understanding how to best give the medicine to patients in the future.

Key takeaways

This study is testing a new tablet form of a medicine called emodepside for treating parasitic worms.
It's an early-stage study for healthy adult volunteers.
The main goal is to see how the medicine is absorbed by the body, and if food affects this.
This research could help develop new treatments for diseases like river blindness.
Taking part involves multiple clinic visits, blood tests, and taking the study medicine.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Because this is a very early study to understand how the medicine works in the body, it is only for healthy people. This means you generally shouldn't have any serious ongoing health problems or be taking a lot of regular medications that might interfere with the study medicine. Specific health checks would be done to make sure you are suitable.

While the study description doesn't list every single requirement, typically for these kinds of early studies, individuals who are pregnant, breastfeeding, or have certain chronic medical conditions would not be able to take part for safety reasons.

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 consider yourself generally healthy?
Are you able to attend several clinic visits?
Are you comfortable with having blood samples taken?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to visit a research clinic several times. During these visits, you'd be given the new emodepside tablet. At some points, you might be asked to take the tablet with food, and at other times, without food, to see how that affects the medicine. Researchers will take regular blood samples to measure how much emodepside is in your system. You might also have other health checks, like blood pressure and heart rate measurements. The total length of your involvement in the study would depend on the specific schedule, but these types of early studies usually involve several clinic visits over a few weeks or months, followed by a final check-up.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is helping scientists gather important information that could lead to new treatments for serious diseases like river blindness in the future. You wouldn't directly benefit from this early study, as it's about learning how the medicine works, not treating an illness. Potential risks could include side effects from the medicine, discomfort from blood tests likened to a routine blood draw, or inconvenience from the clinic visits. All possible side effects will be explained in detail before you agree to take part. 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 is river blindness?

River blindness is an infection caused by a tiny worm spread by blackflies, leading to skin problems and potentially blindness.

What is emodepside?

Emodepside is a medicine currently used to treat worms in animals, and researchers are exploring it for human use.

Who can join this study?

This study is for healthy adults, aged 18 and over, both men and women.

Will I get paid to take part?

The study information doesn't say if participants are paid, but this is a common question to ask the study team.

What will I have to do in the study?

You'll take a study drug, have blood tests, and health checks over several clinic visits to see how your body handles the medicine.