Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

B3461114- A Phase 1, Open-Label, Randomized, Three-Treatment, Three-Period, Crossover, Single Dose Study to Estimate the Relative Bioavailability of 61 mg and 70 mg Tafamidis Free Acid Tablets to Commercial 61 mg Tafamidis Free Acid Capsule Administered Under Fasted Conditions in Healthy Adult Participants

This study is a small, early-stage trial looking at a medicine called tafamidis. Tafamidis is used to treat a heart condition called transthyretin amyloid cardiomyopathy. Researchers are comparing two new forms of tafamidis (a 61 mg and a 70 mg tablet) with the standard 61 mg capsule that’s already on the market. They want to find out how much of the medicine gets into the body and how quickly, to make sure any new versions are absorbed correctly. This is done by giving healthy adults single doses of each type of tafamidis over different time periods, without food.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

12 Feb 2024

aransthyretin amyloid cardiomyopathy

What is this study about?

This study is all about a medicine called tafamidis, which helps people with a specific heart condition called transthyretin amyloid cardiomyopathy. In this condition, abnormal proteins build up in the heart, making it difficult for the heart to pump blood properly.

The main goal of this particular study is to compare new versions of the tafamidis medicine – specifically a 61 mg tablet and a 70 mg tablet – with the 61 mg capsule that doctors can already prescribe. By doing this, scientists want to figure out if these new tablets release the medicine into the body in a similar way to the existing capsule. This is an important step to ensure that any new forms of the medicine would be just as effective and safe for patients.

This kind of research is called a Phase 1 study, which means it's one of the first times a new form of a medicine is being tested in people. It helps medical experts understand how the body handles the medicine – for example, how much of it gets absorbed and how quickly it reaches its highest level in the blood. If these new forms prove to be similar to the existing medicine, it could potentially offer more options for patients in the future.

Key takeaways

This is an early-stage study (Phase 1) on the medicine tafamidis.
It's comparing different forms of tafamidis (tablets versus capsule).
The main goal is to see how the body absorbs the medicine.
Healthy adults aged 18 and over are wanted for this study.
Participation involves taking single doses and having blood tests.
The research aims to improve future treatment options for a heart condition.

Who may be eligible?

To join this study, participants need to be healthy adults aged 18 or older.

Because this is a study designed to understand how the body handles the medicine, and not to treat a specific illness, only healthy volunteers are invited to take part. This ensures that any changes seen in the study are due to the medicine itself and not other health conditions.

Both men and women are welcome to participate in this research.

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 follow study instructions carefully?
Are you comfortable having blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive single doses of tafamidis on three separate occasions. These doses would be given over different periods of time. You would switch between the different forms of tafamidis (the 61 mg tablet, the 70 mg tablet, and the 61 mg capsule) as part of the study.

Before taking the medicine, you would be asked not to eat any food for a certain amount of time. After each dose, you would have blood samples taken at various times to check how much of the medicine is in your body. There might also be other health checks throughout your time in the study. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail before you agree to join.

Potential risks and benefits

The main benefit of taking part in a study like this is helping researchers learn more about medicines, which can ultimately lead to better treatments for patients in the future. As with any medicine, there is a chance of side effects, even in healthy individuals. The study team will explain all known potential risks and monitor you closely. 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
Belgium

Common questions

What is tafamidis?

Tafamidis is a medicine used to treat a specific heart condition called transthyretin amyloid cardiomyopathy.

Why is this study being done?

This study is comparing new forms of tafamidis (tablets) with the existing capsule to see if they are absorbed similarly by the body.

Who can take part in this study?

Healthy adults aged 18 or over, both men and women, are eligible to join.

Will I get the medicine for my heart condition in this study?

No, this study is for healthy volunteers to test how the medicine is absorbed, not to treat the heart condition itself.

What will happen if I join?

You will receive single doses of different tafamidis forms and have blood tests to measure how the medicine gets into your body.