Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants with Schizophrenia

This study is trying to find out if a new version of the medicine olanzapine (called TV-44749) works in the body in the same way as the olanzapine pills currently available. Olanzapine is a medicine often used to help people with schizophrenia. This is a very early study, sometimes called a 'Phase I' study, which means it's one of the first times it's being tested in people. Researchers want to compare how the body takes in, uses, and gets rid of the new medicine versus the standard pills. The main goal is to make sure the new version is absorbed similarly, which is important for it to be effective and safe. It involves participants aged 18 and older, and welcomes both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Enrolment target

Start

07 May 2024

Schizophrenia

What is this study about?

This study is about a medicine called olanzapine, which is used to treat schizophrenia. Schizophrenia is a condition that can affect a person's thoughts, feelings, and behaviour. Currently, olanzapine is usually taken as a pill. Researchers are looking at a new version of this medicine, called TV-44749, to see how it works in the human body.

The main purpose of this study is to compare the new version of the medicine with the regular olanzapine pills. The researchers want to know if the body absorbs and uses the new medicine in the same way as the existing pills. This is very important because it helps them make sure that if this new version were to be used in the future, it would have the same effects and be just as safe as the current treatment.

This is a very early stage of research, known as a 'Phase I' study. This means it's one of the first times this new version of the medicine is being tested in people. Studies like this are vital steps before a new medicine can be made widely available. They help scientists understand the basics of how a drug behaves in the body, which is crucial for developing better treatments in the future.

Key takeaways

This study is comparing two forms of olanzapine medicine.
It's an early-stage study to see how the body uses the new medicine.
Participants must be 18 or over and have schizophrenia.
Both men and women are welcome to take part.
Your health would be carefully monitored throughout the study.
You can stop participating at any time.

Who may be eligible?

To join this study, participants should generally be aged 18 or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to join this research.

More detailed requirements would be discussed with the study team, but generally, participants would need to have schizophrenia. Other health conditions or medicines you are currently taking might affect whether you can participate, as highlighted by a doctor during an assessment.

The exact rules about who can and cannot take part are very important to make sure the study is safe and that the results are clear. If you're interested, the study team would go through all these details with you to see if you're a good fit.

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 have a diagnosis of schizophrenia?
Are you able to attend clinic visits as required?
Are you comfortable with blood tests?
Are you willing to potentially try a new form of medication?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a few steps. You would first have a screening visit to check if you are suitable. If you are, you would then attend a clinic for the study medicine. This study compares two forms of olanzapine, so you might take the new version (TV-44749) and a standard olanzapine pill at different times.

During your time in the study, you would likely have blood tests taken regularly to see how the medicine is working in your body. There would also be check-ups to monitor your health and how you are feeling. The exact number of visits, tests, and the total length of your participation would be explained fully by the study team before you decide to join.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of closely monitored medical care and contributing to the development of new treatments for schizophrenia. However, there are potential risks, as with any medicine. These could include side effects from the study medicine, or the discomfort of blood tests. All known potential risks and side effects would be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Spain
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Unverified
France
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Unverified
Croatia

Common questions

What is the main goal of this study?

The main goal is to compare how a new version of olanzapine (called TV-44749) works in the body compared to the standard olanzapine pills.

What is olanzapine used for?

Olanzapine is a medicine often prescribed to help people who have schizophrenia.

Do I have to have schizophrenia to join?

Yes, this study is specifically looking for participants who have a diagnosis of schizophrenia.

How long will I be in the study?

The exact duration of your participation, including visits and follow-up, will be fully explained by the study team.

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 medical care.