Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

(22081) Open-label, fixed sequence crossover study to determine the effects of a single dose of elinzanetant (BAY 3427080) on the pharmacokinetics of dabigatran etexilate in healthy participants

This research study, called (22081), is testing how a new medicine, BAY 3427080, interacts with a commonly used blood-thinning drug called dabigatran, also known as Pradaxa. The study is open to healthy volunteers, both men and women. Researchers will give participants a single dose of both medicines, either separately or together, to see if BAY 3427080 changes how much dabigatran is absorbed into the body and how long it stays there. The main goal is to understand if these medicines can be safely taken at the same time without affecting the dabigatran levels. The study is a "Phase 1" human pharmacology study, meaning it's one of the first times this interaction is being looked at in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer Consumer Care AG, Bayer AG

Enrolment target

Start

28 Jul 2022

Healthy volunteers (Vasomotor Symptoms as a sex hormone-dependent disorder in women and men)

What is this study about?

This study is designed to understand how two different medications might work together in your body. One of the medicines is called dabigatran, which you might know by its brand name, Pradaxa. This drug is often used as a blood thinner to prevent clots.

The other medicine being studied is a new one called BAY 3427080. It's currently being developed and is in the early stages of testing. The purpose of this study is to see if taking BAY 3427080 at the same time as dabigatran changes how your body handles the dabigatran. We want to know if it changes how much dabigatran gets into your blood or how quickly your body gets rid of it.

This is important because if one medicine affects the levels of another, it could change how effective or how safe the treatment is. By understanding this interaction early on, doctors can make sure that if these medicines are ever prescribed together in the future, it can be done safely and effectively.

Key takeaways

The study looks at how a new drug (BAY 3427080) affects an old one (dabigatran).
It aims to see if taking them together changes blood levels of dabigatran.
Healthy adults, both men and women aged 18 and over, can take part.
Participation involves taking medicines and giving blood samples.
It's a research study with no direct personal health benefits expected.

Who may be eligible?

This study is looking for healthy adults to take part. This means that to be eligible, you generally shouldn't have any major ongoing health problems, and you shouldn't be taking medications that might interfere with the study.

Both men and women are welcome to participate, as long as they are at least 18 years old. There is no upper age limit specified, as long as you meet the other health requirements.

Keep in mind that even if you consider yourself healthy, there will be a screening process to make sure you fit all the detailed criteria for the study. This might include health checks and discussions about your medical 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 at least 18 years old?
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 currently taking any medications that could interfere with the study? (This will be checked by the study team)

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 multiple times. During these visits, you will receive either dabigatran, BAY 3427080, or both, at different times according to a set plan. The medicines will be given as capsules. To measure how your body handles the medicines, blood samples will be taken regularly after you've taken the medication.

The study will also involve checking for any side effects you might experience. This means you'll be monitored closely, and you'll be asked to report any new or unusual feelings or symptoms. The total duration of your participation, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Potential benefits of participating include contributing to medical research that helps us understand how new and existing medicines work together, which can improve future patient care. You will also receive health checks as part of the study. However, there's no direct personal medical benefit expected for you from taking part. Potential risks include experiencing side effects from the study medications, as well as discomfort from blood draws. While efforts are made to minimise risks, not all side effects can be predicted. You have the right to withdraw from the study at any time, for any reason, without penalty or 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 dabigatran (Pradaxa)?

Dabigatran, also known as Pradaxa, is a medicine used to thin the blood and help prevent blood clots.

What is BAY 3427080?

BAY 3427080 is a new medicine being developed that is in the early stages of testing in people.

Why are you giving these medicines together?

We are studying if taking the new medicine, BAY 3427080, changes how your body handles dabigatran, to ensure they can be used safely together if needed in the future.

What is a 'healthy volunteer'?

A healthy volunteer is someone who does not have any major ongoing medical conditions that would affect the study results or put them at undue risk.

Will I receive any direct medical benefit from joining?

No, this study is for research purposes, and there is no direct personal medical benefit expected for participants.