Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

C5041034 - A Phase 1, Open-Label, Randomized, Single Dose, Crossover Study to Estimate the Relative Bioavailability of Etrasimod (PF-07915503) Mini Tablets in Water and 3 Food Vehicles Compared to the Etrasimod (PF-07915503) Clinical IR Tablets Under Fasted Conditions, and to Evaluate Mini Tablet Palatability in Healthy Adult Participants

This research study is testing a medicine called etrasimod, which is being developed for conditions where the body's immune system mistakenly attacks its own tissues, such as ulcerative colitis, alopecia (hair loss), and eczema. We want to understand how well the body absorbs etrasimod when taken as a small tablet with water or different foods. We're also checking how people feel about taking these tiny tablets. This is an early-stage study in healthy adult volunteers to help us learn more about the medicine before it's given to people with the actual conditions. The main goal is to find out the best way to deliver the medicine so it can help patients more effectively in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

12 Jun 2023

immune-mediated inflammatory disorders, including ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis

What is this study about?

This study is a bit like a taste test, but for medicine! We're looking at a new medicine called etrasimod. This medicine is designed to help people with what are called 'immune-mediated inflammatory disorders'. These are conditions where the body's defence system (your immune system) mistakenly causes swelling and damage. Examples include ulcerative colitis (a bowel condition), alopecia areata (a type of hair loss), and eczema (a skin condition).

In this study, we're trying to work out the best way to give etrasimod as tiny tablets, often called 'mini tablets'. We want to see how well your body takes in the medicine when you swallow these mini tablets with just water, or with different types of food. We'll compare this to a standard tablet form. We also want to know what people think about how these mini tablets feel when they swallow them – do they taste bitter? Do they burn? This information is really important because it helps future patients take their medicine easily.

This is a very early stage study, called a 'Phase 1' study. It involves healthy adults, not people who have the conditions mentioned. This helps us understand how the medicine works in general, such as how it's absorbed and processed by the body, before we move on to testing it in people who might benefit from it for their health problems. The overall aim is to make sure that if etrasimod can help people, it's given in the best possible way.

Key takeaways

This study tests how a new medicine, etrasimod, is absorbed by healthy adults.
It compares small 'mini tablets' with water and different foods.
The main goal is to find the best way to deliver the medicine for future patients.
It's an early-stage (Phase 1) study for conditions like ulcerative colitis and eczema.
Participants will have regular health checks and give blood samples.
Your feedback on the mini tablets' feel and taste is important.

Who may be eligible?

This study is looking for healthy adult volunteers. To take part, you need to be at least 18 years old – there's no upper age limit, as long as you're in good health.

Both men and women can participate in this research. The most important thing is that you are generally healthy, as confirmed by medical checks, to ensure the study is safe for you and the results are clear.

Because this study is about how the body handles the medicine, there will be specific health checks, including blood tests and heart tests. These are to make sure you don't have any underlying conditions that might affect how the medicine works or cause you problems.

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 in good health?
Are you able to attend several clinic visits?
Are you comfortable with having blood samples taken?
Are you able to follow specific instructions regarding food and medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic multiple times. During these visits, you'll be given different forms of the etrasimod medicine – sometimes with water, sometimes with different foods. This is to see how your body absorbs the medicine in each situation. You'll switch between these different ways of taking the medicine which is called a 'crossover' design.

After taking the medicine, blood samples will be taken regularly to measure the level of etrasimod in your body over time. You will also have other health checks, such as measurements of your heart rate, blood pressure, and general health (like physical exams and heart tracings called ECGs). You'll also be asked to fill out questionnaires about how the mini tablets feel when you take them – for example, if they taste bitter or cause any burning sensation. The total duration of your participation will involve these clinic visits and follow-up checks, spanning over several weeks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You won't directly benefit from this study, as it's designed to gather information for future patient use, and you will be healthy. However, you will be contributing to important scientific knowledge that could help people with serious health conditions in the future. Potential risks could include mild side effects from the medicine, discomfort from blood tests, or minor temporary changes in vital signs. The study team will monitor you closely for any issues, and you will be fully informed of all known risks before you agree to participate. Remember, you can choose to leave 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
Belgium

Common questions

What kind of conditions is etrasimod meant to treat?

Etrasimod is being developed for immune conditions like ulcerative colitis (a gut problem), alopecia areata (hair loss), eczema (a skin condition), and eosinophilic esophagitis (a food tube condition).

Am I going to be given the actual medicine for my condition?

No, this study is about how healthy people absorb the medicine, not to treat any specific condition. You need to be healthy to join.

What does 'Phase 1' mean?

Phase 1 means this is one of the very first human studies of the medicine. It's usually done in healthy volunteers to understand how the medicine is handled by the body and check for safety.

Will I have to eat specific foods?

Yes, to see how food affects the medicine, you will take the medicine with different types of meals or drinks as instructed by the study team.

Will I be paid for taking part?

The study does not specify payment, but many early-stage studies offer compensation for your time and travel. You should ask about this directly.