Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn how much elinzanetant gets into the blood, how safe it is and how it affects the body after taking single and multiple amounts in healthy subjects

This study is exploring a new medicine called elinzanetant. It's designed to understand how the medicine moves through and affects the body. Researchers will give participants different amounts of elinzanetant, both once and repeatedly, to see how much of it gets into the blood, how safe it is, and what effects it has. The main purpose is to learn about this new drug in healthy adults before it's tested in people with specific health conditions. This type of early study helps ensure that future research can be done safely and effectively.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer Consumer Care AG, Bayer Consumer Care AG, Bayer AG

Enrolment target

Start

08 Aug 2023

Vasomotor Symptoms as a sex hormone-dependent disorder in women and men

What is this study about?

This research study is about a new medicine called elinzanetant. The main goal is to understand how this medicine works inside the human body. Think of it like a first look at a new product. Researchers want to see how much of the medicine enters your bloodstream after you take it, how long it stays there, and how the body handles it.

They will also be carefully checking for any side effects or changes in your health to make sure the medicine is safe. Participants in this study will be healthy adults, meaning they don't have any major ongoing health problems. This is an important early step in developing any new medicine. By studying it in healthy people first, scientists can get a clear picture of its basic effects and safety without other health issues getting in the way. This information is then used to design future studies, possibly in people who might benefit from the medicine.

While the study itself isn't directly focused on treating hot flushes or other related symptoms (which are sometimes called vasomotor symptoms), the information gained from this early research will be vital for understanding if elinzanetant could be a helpful treatment for these symptoms in the future. It's a foundational step to see if the medicine behaves as expected in people.

Key takeaways

This is an early study of a new medicine called elinzanetant.
It aims to understand how the medicine behaves in the body and if it's safe.
The study is for healthy adults, both men and women, aged 18 and over.
Participation involves taking the medicine and attending medical check-ups.
It helps science learn about a potential future treatment but offers no direct personal health benefit.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should generally be in good health and not have any significant ongoing medical conditions that could interfere with the study or make participation unsafe for you.

To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older adults could also be eligible, as long as they meet the other health criteria. The study welcomes both men and women to participate.

Because this is a very early-stage study, the researchers will be very thorough in checking your health to make sure you are suitable and that taking part would be safe for you. This will likely involve medical checks and a review of your health history.

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 generally healthy with no major ongoing medical conditions?
Are you 18 years old or older?
Are you able to attend several appointments at the study clinic?
Are you comfortable with blood tests and other medical checks?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be given the study medicine, elinzanetant, both as single doses and then as multiple doses over time. You will need to attend several appointments at the study clinic. These visits will involve various medical checks, such as blood tests, careful monitoring of your vital signs (like blood pressure and heart rate), and possibly other tests to see how the medicine is affecting your body. You will be closely observed, especially after taking the medicine.

Some of these visits might involve staying at the clinic for a short period, and you will have follow-up appointments after you've finished taking the medicine to make sure you're well and to continue monitoring its effects. The total duration of your involvement, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you would contribute to medical science, helping researchers learn more about a new medicine that could potentially help others in the future. However, there is no direct personal health benefit for you as a participant. Potential risks include experiencing side effects from the experimental medicine, which could be mild (like headaches or nausea) or, less commonly, more serious. There's also the inconvenience of time commitment and medical procedures like blood draws. You have the right 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.

—
Unverified
Germany

Common questions

What is elinzanetant?

Elinzanetant is a new medicine that researchers are studying. This particular study is an early step to understand how it works in healthy people.

Why is this study being done in healthy people?

Studying the medicine in healthy people first helps researchers understand its basic effects and safety without other health conditions making things more complicated. It's an important first step.

Will I get better if I join this study?

This study is not designed to treat a specific illness, so you should not expect any direct health benefits. Its purpose is to gather information about a new medicine.

What kind of tests will I have?

You'll likely have blood tests, blood pressure checks, and other medical exams to monitor your health and see how the medicine affects your body.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.