Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

(22424) Exploratory, randomized, non-blinded, crossover study to investigate the relative bioavailability of different elinzanetant soft gel capsules in healthy participants

This research is a Phase I study, which means it's an early step in developing a new medicine. The drug being tested is called elinzanetant, which is designed to help with hot flashes and night sweats (vasomotor symptoms) that can affect both men and women. Researchers want to compare different types of elinzanetant soft gel capsules. They'll give each participant different versions of the medicine and measure how much of the drug gets into their blood over time and how quickly it gets there. This helps them find the most effective and reliable way to deliver the medicine. Participants will be healthy adults, both men and women, and the study will also track any side effects to ensure safety.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer Consumer Care AG, Bayer AG

Enrolment target

Start

14 Jul 2023

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

What is this study about?

This study is about a new medicine called elinzanetant, which is being developed to help with hot flashes and night sweats. These symptoms can be really uncomfortable and are often linked to changes in hormones in both women and men. Before a new medicine can be widely used, scientists need to understand how it behaves in the body.

In this particular study, researchers are focusing on different forms of the elinzanetant medicine that come in soft gel capsules. They want to see if one type of capsule delivers the medicine to the body better than another. This involves measuring how much of the medicine gets into the bloodstream and how quickly, which helps them decide which capsule design is most effective and consistent for future use. Think of it like comparing different ways to deliver a package – you want to know which method gets the package to its destination fastest and with the most complete contents.

This is an important early step in developing the medicine. By understanding how the drug is absorbed, the researchers can make sure that people who might need this medicine in the future will get the right amount to help them feel better, safely and effectively. It’s all about finding the best way for the body to use the medicine.

Key takeaways

This study is testing a new medicine called elinzanetant for hot flashes.
It's an early-stage study to see how the medicine is absorbed by healthy bodies.
Participants will try different versions of the medicine in soft gel capsules.
Blood samples will be taken to measure medicine levels in the body.
Your safety will be closely monitored throughout your participation.

Who may be eligible?

This study is looking for healthy adult volunteers. If you are 18 years old or older, you might be able to take part. Both men and women are welcome to participate in this research.

Since this study is designed to understand how the medicine works in a healthy body, you would typically need to be in good general health. This means you shouldn't have any major ongoing health problems or be taking medications that could interfere with the study. The research team will do medical checks to make sure it's safe for you to join.

The main goal is to see how different forms of the medicine are absorbed, so it's not looking for people who currently have hot flashes or night sweats. It's about healthy volunteers helping to develop a future treatment.

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 healthy and don't have any major ongoing medical conditions?
Are you available for multiple study visits, including some where you'll need to be fasted?
Are you comfortable with giving blood samples?
Are you willing to follow all study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given different versions of the elinzanetant medicine over several visits. This is called a 'crossover' study, meaning you'll get each type of capsule at different times, so the researchers can compare them fairly. You won't know which type of capsule you're getting at a specific time, but the researchers will.

During your time in the study, you will have blood samples taken after you've taken the medicine, usually when you haven't eaten (fasted). This helps the researchers measure how much of the drug is in your blood and how quickly it gets there. You will also be carefully monitored for any side effects or changes in your health. The total duration of your involvement will include multiple visits and follow-ups, which will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might not offer a direct health benefit to you, as you are healthy and not receiving treatment for a specific condition. However, your participation is invaluable for advancing medical knowledge and helping to develop new treatments for hot flashes and night sweats, which could benefit many others in the future. As with any medicine, there's a chance of experiencing side effects, though early-stage studies are designed to detect even minor ones. The research team will tell you about all known or possible risks before you agree to take part. Remember, 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.

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Unverified
Germany

Common questions

What are "vasomotor symptoms"?

These are common symptoms like hot flashes (or hot flushes) and night sweats, which can make you feel suddenly hot and sweaty, often uncomfortable, and can disrupt sleep.

Why is this study using healthy volunteers?

Using healthy volunteers allows researchers to understand how the medicine is absorbed and processed by the body without the complications of existing health conditions. It's a crucial first step in testing a new drug.

What does 'crossover study' mean?

It means you'll try each different type of medicine capsule at separate times during the study. This helps researchers compare them directly within the same person.

Will I know which medicine I'm taking?

No, this is a non-blinded study for the researchers (they know), but you as a participant won't know which specific capsule type you're taking at any given time. This helps keep the results unbiased.

What happens if I feel unwell during the study?

The research team will monitor you closely, and you should tell them immediately if you feel unwell or notice any changes. Your safety is their priority.