Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

KF2024#1 trial: Esketamine interaction study

This study, called KF2024#1, is a very early stage of research to understand how the body handles a medicine called esketamine. We're inviting healthy volunteers to take part. The main goal is to see how the drug is absorbed, used, and cleared from the body, and to compare it with another similar drug. This helps us understand if the new drug works in the same way. This kind of study is really important to make sure new medicines are safe and work as expected before they can be used more widely. Your participation helps advance medical science.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

HUS-Yhtymae

Enrolment target

Start

01 Nov 2024

healthy volunteers

What is this study about?

This study, known as the KF2024#1 trial, is a very early step in checking how a new medicine called esketamine works. In simple terms, we want to see what happens to the drug once it enters the body of healthy people. We'll be looking at things like how quickly it gets into your bloodstream, how long it stays there, and how your body gets rid of it.

This type of research, often called a 'Phase I' study or a 'bioequivalence' study, is really important. It helps us understand if the new esketamine formulation acts in the same way as another established version of the drug. If two medicines are 'bioequivalent,' it means they deliver the same amount of active drug to the body at the same rate, so they should have the same effects.

By carefully studying healthy volunteers, we can gather essential information about the new medicine's properties. This information is a crucial step before the drug can be tested in people who have specific health conditions. It helps ensure that new treatments are thoroughly understood and deemed safe enough for further research, eventually aiming to help patients in the future.

Key takeaways

This is an early-stage study involving healthy volunteers.
It aims to understand how the body handles a medicine called esketamine.
Your participation helps advance medical understanding.
Safety is a top priority, and you'll be closely monitored.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults to take part. To be eligible, you must be 18 years old or older – there's no upper age limit for now.

The study welcomes both men and women to participate. The most important thing is that you are generally healthy and do not have any major ongoing medical conditions that could affect the study results.

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 follow instructions from the study team?
Are you available for clinic visits and follow-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be invited to a clinic for a brief check-up to make sure you are healthy enough. Then, you would likely spend some time at the clinic, possibly overnight or for a few days, depending on the study design. During this time, you would be given the study medication (esketamine).

Over a few hours or days, doctors and nurses would take regular blood and urine samples to see how your body processes the drug. You'd also have your vital signs (like blood pressure and heart rate) checked often. There would be follow-up phone calls or short visits to ensure you're feeling well after leaving the clinic. The total time you'd be involved in the study would be explained fully before you agree to take part.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. You might not directly benefit from this study, but your participation is incredibly valuable as it helps us learn more about new medicines which could help many people in the future. Potential risks could include mild side effects from the drug, such as dizziness or feeling tired, or discomfort from blood tests. All procedures will be explained in detail, and your safety is the top priority. 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
Finland

Common questions

What is esketamine?

Esketamine is a medicine that is being studied. This particular trial is looking at how it works in the body.

Why do you need healthy volunteers?

By studying healthy people, we can understand how the drug works in a 'normal' body without other health conditions making it complicated. This is a vital first step.

Will I get paid for taking part?

Most early-stage studies like this offer some compensation for your time and inconvenience. This would be fully explained before you agree to join.

What if I feel unwell during the study?

Study staff will be closely monitoring you. If you feel unwell, you must tell them immediately, and they will provide care and support.

How long does the study last for each person?

The exact duration for your participation will be fully explained to you, but typically early phase studies involve a few days in a clinic, with some follow-up calls or visits.