Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-1117570 in Healthy Adults

This research study is looking at a new medicine called NBI-1117570. It's designed for people with brain and mental health conditions. Researchers want to find out if this new medicine is safe for people to take and how well their bodies handle it. They are also trying to understand how it works inside the body. This is an early phase study, meaning it's one of the first times the medicine is being given to people. They are asking healthy adults to take part to help them understand more about NBI-1117570 before it might be tested in people who have these conditions. The information gathered will be very important for deciding if this medicine could be a useful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Neurocrine Biosciences Inc.

Enrolment target

122

Start

13 Feb 2024

Neurological and neuropsychiatric conditions

What is this study about?

This research study is about a new medicine called NBI-1117570. It's being developed to help people who have certain brain and mental health conditions. These can include things like depression, anxiety, or other conditions affecting how our brains work and how we feel and think. Before any new medicine can be given to patients, scientists need to understand a lot about it.

The main goals of this particular study are to check if the medicine is safe when healthy people take it, to see how the body absorbs, uses, and gets rid of the medicine, and to understand how it affects different parts of the body. This is crucial for making sure that any future use of the medicine would be as safe and effective as possible. Because it's a very early-stage study, healthy adults are being asked to take part.

The information learned from this study will help researchers decide if NBI-1117570 could be a promising treatment for brain and mental health conditions. It's an important step in developing new medicines that could potentially improve the lives of many people.

Key takeaways

This study is testing a new medicine (NBI-1117570) for brain and mental health conditions.
The main focus is to check its safety and how the body handles it in healthy adults.
It's an early-stage study, meaning it's one of the first times this medicine is given to people.
Participants must be healthy adults, aged 18 or over, of any gender.
Taking part helps advance medical knowledge for future treatments.
You can withdraw from the study at any time without any consequences.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you must be at least 18 years old. There is no upper age limit mentioned, so older adults can also be considered.

Both men and women are welcome to participate in this study. The researchers will have a full list of other requirements to make sure it's safe for you to join and that the results of the study are clear. These will likely include things like your overall health, current medications, and medical history.

Before you can take part, a doctor or nurse from the study team will carefully check your health to make sure you meet all the necessary requirements.

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 considered to be in good health?
Are you available for regular study visits?
Are you comfortable potentially taking a new, experimental medicine?
Are you aware that both men and women can participate?
Do you want to help learn about new medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely need to visit the study clinic several times. During these visits, you might have health checks, blood tests, and other assessments to see how the medicine is affecting you. You will be given the new medicine, NBI-1117570, which you might take as a pill or another form, as instructed by the study team.

The study will also involve follow-up appointments after you stop taking the medicine to make sure you are well and to gather any final information. The total amount of time you spend in the study, from your first visit to your last follow-up, will be explained by the study team. It's important to understand that you would be expected to follow all study rules and attend all scheduled appointments.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is contributing to medical science and helping to develop new treatments for serious health conditions. However, since this is a new medicine, there is a chance you might experience side effects. These could be mild, like a headache or feeling tired, or in some rare cases, more serious. The study team will explain all known or potential risks to you in detail. 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
Netherlands

Common questions

What is the main goal of this study?

The main goal is to check if the new medicine, NBI-1117570, is safe and how it works in healthy adults.

Who can take part in this study?

Healthy adults who are 18 years old or older, both men and women, can be considered for this study.

Will I receive the new medicine?

Yes, if you join the study, you will be given the new medicine, NBI-1117570, as part of the research.

Will I have to spend a lot of time at a clinic?

You will need to attend several visits at the study clinic for check-ups and to receive the medicine, but the exact number and length of visits will be explained by the study team.

What if I change my mind during the study?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.