Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Conducting a quality study of the medicinal product - Vortioxetine

This early-stage study is looking at a medicine called Vortioxetine. We're inviting healthy adult volunteers to take part, not people who are ill. The main goal is to see how the body takes in, uses, and gets rid of the medicine. This is called a 'bioequivalence' study and helps confirm that different versions or batches of the medicine act the same way in the body. Although it's being tested in healthy people now, Vortioxetine is being developed as a potential treatment for adults who experience major depression. Your participation could help us understand this medicine better for future use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Biofarm Sp. z o.o.

Enrolment target

Start

01 Apr 2024

No therapeutic indication in the current trial with healthy volunteers. The intended indication is for the treatment of major depressive episodes in adults

What is this study about?

This is an early-stage research study, often called a Phase I study. Doctors and scientists are looking into a medicine named Vortioxetine. The main aim of this particular study is to understand how your body handles this medicine. They'll be checking how much of the medicine gets into your bloodstream, how quickly it gets there, and how long it stays in your body.

It's important to know that this study is for healthy volunteers, not for people who are currently unwell or taking other medications. We're not testing if the medicine treats a condition right now. Instead, we're trying to make sure that different forms or batches of Vortioxetine work in the same way once they are inside the body – this is what 'bioequivalence' means. It's a crucial step in the journey of developing any new medicine.

While we aren't treating any condition in this study, the medicine Vortioxetine is being developed with the hope of one day helping adults who experience major depressive episodes. By taking part, you'd be contributing to valuable research that could ultimately benefit many people in the future.

Key takeaways

This study is for a medicine called Vortioxetine, for future use in depression.
It's an early-stage study in healthy volunteers, not people with an illness.
The main aim is to see how the body handles the medicine.
Both men and women aged 18 and over can participate.
Participation involves clinic visits, taking the medicine, and health checks.
You'll contribute to important medical research.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part. Both men and women are welcome.

Crucially, this study is looking for healthy volunteers. This means you shouldn't have any major ongoing health conditions, and you shouldn't be taking regular medications, as these could affect how your body reacts to the study medicine. The research team will do medical checks to make sure you're suitable.

Because we're looking for healthy individuals, this study is not suitable for people who are currently experiencing depression or any other illness. The aim is to understand the medicine's basic behaviour in a typical healthy body.

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 aged 18 or older?
Do you consider yourself generally healthy?
Are you currently not taking any regular medications?
Do you have any major ongoing health conditions?
Are you available for multiple clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, Vortioxetine. The study will likely involve several visits to a clinic or research facility. During these visits, the research team will monitor you closely. This will include taking blood samples to measure how much of the medicine is in your body at different times, as well as checking your general health through things like blood pressure readings and possibly ECGs (heart tracings).

Details about the exact number of visits, how long each visit will be, and the total duration of your involvement (including any follow-up calls or visits after you finish taking the medicine) will be explained fully by the study team. You'll receive a schedule outlining everything involved before you agree to participate.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical science, which could help people with depression in the future. You may also receive a reimbursement for your time and travel. Potential risks could include side effects from the study medicine, even though it's being tested in healthy people and at a carefully chosen dose. There might also be discomfort from blood tests or other procedures. You will be closely monitored, and 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
Bulgaria

Common questions

What is Vortioxetine?

Vortioxetine is a medicine being developed to treat adults with major depression. In this study, we're just checking how it works in healthy bodies.

Why are you testing it on healthy people?

Testing on healthy volunteers helps us understand how the medicine behaves in the body without other illnesses or medications complicating the results. It's a standard first step for new medicines.

Will this medicine treat my depression?

No, this specific study is not designed to treat depression. We are only observing how healthy bodies process the medicine.

How long will I be involved in the study?

The exact duration will be explained by the study team. It will involve several visits to the clinic over a set period, possibly with follow-up calls afterwards.

Do I have to take part if I'm interested?

No, showing interest doesn't commit you. You'll receive all the information, and you only join if you fully understand and agree to everything. You can also leave the study at any point.