Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study to establish the bioequivalence of free acid tafamidis 61 mg capsule and tablet, and evaluate the safety and tolerability of the 61 mg tablet in healthy adults

This study is looking at a medicine called tafamidis, which is used for a condition called transthyretin amyloidosis. The main goal is to compare a new tablet form of tafamidis with its existing capsule form. Scientists want to make sure both forms work the same way in the body. They will test both in healthy adults. The study will also carefully check if the new tablet form causes any side effects or problems. This is an early-stage study, meaning it's focusing on how the medicine behaves and its safety in healthy people, rather than its effects on the illness itself.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pfizer Inc.

Enrolment target

Start

14 Nov 2024

Transthyretin amyloidosis

What is this study about?

Imagine you have a new medicine that comes in a capsule, and doctors think a tablet version might be easier for patients. Before switching, they need to be really sure the tablet works just like the capsule. That's what this study is all about for a medicine called tafamidis, which helps people with a condition called transthyretin amyloidosis. This condition involves abnormal protein deposits in the body that can affect organs like the heart and nerves.

Researchers want to see if the new tafamidis tablet delivers the medicine into the body in the same way as the current capsule. This is very important. If they don't work the same, it could mean patients get too much or too little medicine, which isn't good. They call this 'bioequivalence'. Alongside this, they will also be closely watching to see how safe the tablet form is and if it causes any unwanted effects in healthy people.

This is an early stage of research, often called a 'Phase I' study. These types of studies are usually done with healthy volunteers, not people who have the illness. This helps scientists understand how the medicine is absorbed, distributed, processed, and removed from the body, and to identify common side effects, before it's given to patients who are unwell. It's a crucial step to make sure any new medicine or new form of a medicine is well understood.

Key takeaways

Tests if a new tablet version of tafamidis works the same as the capsule.
Aims to check the safety of the new tablet in healthy adults.
This is an early-stage study (Phase I) for research, not a treatment.
Participants must be healthy, aged 18 or over, male or female.
Your contribution helps improve medicines for future patients.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or older. There is no upper age limit, meaning older adults are welcome to participate if they meet the other health requirements.

Both men and women can join this study. The researchers are looking for people who are generally well and don't have any serious ongoing health problems that might affect how the medicine works or make it unsafe for them to take part. Detailed health checks will be done before anyone is accepted into the study.

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 study visits regularly?
Are you willing to take the study medicine and have blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive doses of both the tafamidis capsule and the new tablet form. You would be monitored closely by medical staff. This would likely involve several visits to a clinic over a period of time, where doctors would take blood samples to check how the medicine is absorbed and leaves your body. They would also monitor your general health and ask about any side effects you might experience. The exact number of visits, tests, and the total length of your participation would be fully explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, as its main aim is to gather information about the medicine. However, you would contribute to medical knowledge that could help future patients. Potential risks could include side effects from the medicine, mild discomfort from blood tests, or inconvenience from clinic visits. 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 used for?

Tafamidis is a medicine used to treat transthyretin amyloidosis, a condition where abnormal proteins build up in the body.

Why are they comparing a capsule and a tablet?

They want to make sure a new tablet form delivers the medicine into the body in the same way as the current capsule form, and to check its safety.

Will I get the medicine for my condition if I join?

No, this study is for healthy volunteers, not people with transthyretin amyloidosis, so it won't treat any illness.

What does 'bioequivalence' mean in simple terms?

It means checking if two forms of a medicine (like a capsule and a tablet) work in the same way once they are in your body.

Do I have to stay in the clinic forever?

No, you would have specific clinic visits, and the study team will explain the full schedule.