RecruitingPhase IInterventional

A Study to evaluate novel KarX and KarT Prototypes versus the KarXT and KarX-EC reference following single doses, and to explore the effect of food after multiple doses of selected prototypes in healthy adult participants

This early-stage study is looking at several new forms of a medicine, currently used for schizophrenia in the US, to see if they could help treat Alzheimer's disease and autism. Researchers want to make the medicine easier to take and potentially reduce side effects. The study will check how safe these new forms are, how much of the medicine gets into the blood, and if eating food changes how the body handles the medicine. Healthy adults aged 18-55 will take different versions of the medicine, some as single doses and some over several weeks. Scientists hope this research will lead to better treatments for serious conditions in the future.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

27 Jun 2025

Estimated completion

16 Sep 2026

Alzheimer's disease and Autism spectrum disorder

What is this study about?

This research study is focused on a new medicine that could potentially help people with Alzheimer's disease or autism. Alzheimer's is a condition that affects memory and thinking, while autism is a condition that affects how people interact and learn. The medicine being tested is an updated version of one already used in the US for another condition, but researchers want to make it better and safer, especially for younger people or those who might find it hard to swallow pills.

The main goal of the study is to see if these new versions of the medicine are safe and how the body handles them. This involves checking for any side effects and measuring how much of the medicine gets into the blood. They also want to understand if taking the medicine with food changes how it works. By doing this early research, scientists can figure out the best way to develop these new medicines so they can eventually help patients.

This is a 'Phase I' study, which means it's one of the first times these new medicine forms are being tested in people. It’s done with healthy volunteers, not patients, to carefully gather information on safety and how the body processes the medicine before it's given to people with the actual conditions. The information gathered here is really important for developing new and potentially more effective treatments in the future.

Key takeaways

This is an early-stage study testing new forms of a medicine for Alzheimer's and autism.
It aims to make the medicine easier to take and safer.
Healthy adults aged 18-55 are needed as volunteers.
Participation involves taking medicine, often staying in a clinic overnight, and regular health checks.
There's no direct medical benefit for volunteers, but it could help develop future treatments.
The study is expected to run from April 2025 to September 2026.

Who may be eligible?

To join this study, you need to be a healthy man or woman between 18 and 55 years old. The research team will do a thorough health check, including a medical history, physical exam, and blood tests, to make sure you are in good health. Your weight should also be within a healthy range for your height.

There are also some reasons why you might not be able to join. For example, if you have or have had serious heart, lung, liver, kidney, digestive, or certain other long-term health problems, you likely won't be able to participate. This is because these conditions could affect how the medicine works or might put your health at risk during the study.

If you're a woman who could become pregnant, you'll need to use specific birth control methods during the study. The same applies to men who are sexually active with women who could become pregnant. The study team will explain these requirements in detail to ensure everyone's safety.

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 between 18 and 55 years old?
Are you generally healthy and don't have major long-term health conditions?
Is your weight (Body Mass Index) within a healthy range (18.0 to 32.0 kg/m²)?
Are you willing and able to follow study instructions, including using specific birth control if needed?
Can you commit to attending all required clinic visits and stays?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be giving different forms of the study medicine, mostly as capsules you swallow. In some parts of the study, you'll take a single dose, and in others, you might take the medicine twice a day for a few weeks (up to 21 days). Some doses might be given with soft food to see if it changes the effect.

You'll need to stay at the clinic for several nights at a time for monitoring – this could be for up to 25 nights across a few separate stays. During your time in the clinic, the study team will closely monitor your health and take measurements like blood samples to see how your body is responding to the medicine. The total study duration, from start to finish, could be between 12 and 21 weeks, depending on which part of the study you participate in.

Potential risks and benefits

You won't directly benefit from the medicine you receive in this study because it's designed to gather information, not to treat a condition you have. However, the information learned could help develop new treatments for people with Alzheimer's disease or autism in the future. As with any medicine, there's a chance of side effects, and the study team will provide you with full information about these beforehand. Your health will be carefully watched throughout the study to ensure your safety, and you are free to leave the study at any time.

Locations (1)

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

Quotient Sciences Limited
City only
Nottingham, England

Common questions

What is Alzheimer's disease?

Alzheimer's is a brain condition that slowly damages memory, thinking skills, and eventually the ability to carry out simple tasks.

What is autism spectrum disorder?

Autism is a condition that affects how people interact, communicate, learn, and behave.

Why are healthy people needed for this study?

Healthy volunteers help researchers understand how a new medicine works in the body and what its potential side effects are before it's given to people with an illness.

Will I get paid for taking part?

The information provided does not say if participants will be paid. You should ask the study team about this.

Where is this study taking place?

The study is being run from Bristol-Myers Squibb Services Unlimited Company in Ireland.

How to find out more

. BMS Clinical Trials Contact Center

Clinical.Trials@bms.com +1 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.