Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

C5241014- A Randomized, Phase 1, Single-Blind, Multi-Period Study to Investigate the Palatability of PF-07923568 Oral Suspension in Different Liquid Vehicles in Healthy Adult Participants

This research study is looking at a new liquid medicine to treat RSV, a common breathing illness. Before this medicine can be given to people who are sick, researchers need to find the best way for it to taste. This study asks healthy adult volunteers to try small amounts of the medicine mixed with different everyday drinks. They will then rate how it tastes, including its sweetness, bitterness, and overall pleasantness. This helps scientists make sure the medicine is easy to take, especially for children or others who might struggle with unpleasant-tasting medicines. Safety is also being checked.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

17 Jul 2023

RSV (respiratory syncytial virus)

What is this study about?

This study is about a new medicine called Sisunatovir, which is being developed to treat a common breathing illness called RSV (Respiratory Syncytial Virus). RSV can cause colds and more serious chest infections, especially in babies and older people.

Before any new medicine can be given to patients, researchers need to make sure it's not only safe and effective but also that people can actually take it without too much difficulty. For a liquid medicine, especially one that might be given to children, how it tastes is really important. If a medicine tastes bad, people might not take it, and then it won't work.

So, this study is focusing on something called 'palatability,' which just means how pleasant or unpleasant something tastes. Healthy adult volunteers are helping by trying different versions of the liquid medicine mixed with various everyday drinks. They will share their opinions on things like sweetness, bitterness, and whether it leaves aFunny taste. This helps the researchers find the best way to mix the medicine so it tastes as good as possible, making it easier for future patients to take.

Key takeaways

Study aims to improve the taste of a new RSV medicine.
Healthy adults will taste small amounts of the medicine.
You will rate the taste, including sweetness and bitterness.
This helps make the medicine easier to take for future patients.
Your health will be monitored throughout the study.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can take part. Both men and women are welcome to join this study.

Because this study is about how the medicine tastes and not about treating RSV, you need to be generally healthy. The study team will check your health to make sure you can safely take part in the taste tests. They will make sure you don't have any medical conditions that would make trying the medicine unsafe.

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 healthy?
Are you willing to try different liquid mixtures?
Are you able to attend several study visits?
Are you comfortable filling out questionnaires about taste?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to try small amounts of the new liquid medicine mixed with different drinks. You won't be given the full dose for treating RSV, just enough to taste. After each taste, you'll fill out a questionnaire, rating things like how sweet, bitter, or pleasant it is. The study will involve several visits over a period of time, where you'll try different mixtures. During these visits, the study team will also check your health by taking your vital signs (like blood pressure and heart rate) and doing some blood and urine tests to make sure you remain well. You'll have follow-up checks after your last taste test. The total duration of your participation in the study, including all visits and follow-ups, will be explained by the study team.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers make a new medicine for RSV easier to take for future patients. You would also receive close medical attention during the study. Potential risks are generally low, as you're only tasting small amounts of the medicine, but you might experience mild side effects, which the study team will monitor closely. You always 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
Belgium

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus, a common virus that causes cold-like symptoms and can lead to more serious breathing problems, especially in babies and older adults.

Why do you need healthy people for a taste test?

We use healthy volunteers because the study is purely about how the medicine tastes, not about treating a disease. This avoids any other health issues confusing the results of the taste test.

Will I get sick from tasting the medicine?

You will only taste very small amounts of the medicine. The study team will closely monitor you for any side effects, and your safety is their top priority.

Do I have to drink the whole amount?

The study team will give you instructions on how much to taste for each test. You won't be asked to consume large quantities, just enough to evaluate the taste.

Will I be paid for taking part?

This is a common question, and any compensation for your time and travel will be fully explained by the study team before you agree to participate.