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Study on How Tafamidis is Absorbed in the Blood of Healthy Adults with Transthyretin Amyloid Cardiomyopathy

InvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying how different forms of the study medicine, tafamidis, are absorbed into the blood in healthy adults. Tafamidis is a medication used to treat a heart condition known as transthyretin amyloid cardiomyopathy, which affects the heart's ability to function properly. The study will compare the absorption of two different tablet forms of tafamidis (61 mg and 70 mg) to a capsule form (61 mg) when taken by healthy participants who have not eaten.

The purpose of the study is to estimate how well the body absorbs these different forms of tafamidis. Participants will receive a single dose of each form of the medication in a randomized order, meaning the order in which they receive the tablets and capsule will be determined by chance. The study will take place over three periods, with each participant receiving all three forms of the medication at different times. This approach helps researchers understand the differences in how the body takes up each form of the medication.

Throughout the study, participants will be monitored to measure the levels of tafamidis in their blood. This information will help determine the relative bioavailability, which is a term used to describe how much of the drug enters the bloodstream and is available to have an effect. The study is designed to ensure the safety and well-being of participants while providing valuable information about the medication's absorption in the body.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the trial's purpose, which is to understand how different forms of the study medicine, tafamidis, are absorbed into the blood.
Participants will be required to provide consent and confirm that they meet the eligibility criteria, such as being 18 years or older and having a body mass index (BMI) between 16 and 32 kg/m².
Step 2
Initial assessment
Participants will undergo an initial medical evaluation, including a review of medical history, a physical examination, and laboratory tests to ensure they are healthy and meet the study requirements.
Step 3
Medication administration
The study involves taking three different forms of tafamidis: a 61 mg tablet, a 70 mg tablet, and a 61 mg capsule.
Each form of the medication will be taken as a single dose, one at a time, under fasted conditions, meaning no food should be consumed before taking the medication.
Step 4
Crossover periods
The study is designed as a crossover trial, which means participants will take each form of the medication in different periods.
There will be three periods in total, and each period will involve taking one form of the medication followed by a washout period to ensure the previous dose is cleared from the body before the next form is administered.
Step 5
Monitoring and follow-up
Participants will be monitored for any side effects or reactions to the medication throughout the study.
Regular follow-up visits will be scheduled to assess the absorption of the medication into the blood and to ensure participant safety.
Step 6
Completion of the study
Upon completion of all study periods and follow-up assessments, participants will have a final evaluation to ensure their health and well-being.
The study is expected to conclude by May 27, 2024.

Who can join the trial?

4 criteria

Participants must be 18 years or older at the time of screening. This means you need to be at least 18 years old to join.
Participants should be healthy females who cannot have children or healthy males. This will be determined by a medical check-up, which includes looking at your medical history, a physical exam, and some lab tests.
Participants must have a body mass index (BMI) between 16 and 32 kg/m². BMI is a number calculated from your weight and height.
Participants must have a total body weight of more than 45 kg (which is about 99 pounds).

Who cannot join the trial?

4 criteria

Participants with any medical condition that might interfere with the study results.
Individuals who are not in the specified age range for the study.
Participants who are not healthy, as the study requires healthy participants.
Individuals who are part of a vulnerable population, which means they might need special protection or care.

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Investigated drugs

Tafamidis Free Acid Tablet
is a medication being tested in this clinical trial. It is designed to help stabilize a protein in the body called transthyretin. This protein can sometimes misfold and form clumps, which can lead to health problems. By stabilizing this protein, the medication aims to prevent these clumps from forming, potentially helping people with conditions related to this issue.
Tafamidis Free Acid Capsule
is another form of the same medication being used in the trial. Like the tablet, it works to stabilize the transthyretin protein in the body. The goal is to see how the capsule form compares to the tablet form in terms of how well it is absorbed and utilized by the body. This comparison helps researchers understand which form might be more effective or easier for the body to use.

Tafamidis

What is already known about the treatment

Tafamidis – Tafamidis is administered orally in the form of tablets or capsules. It is currently being studied in clinical trials to compare the bioavailability of different tablet doses to the existing capsule form. This medication is primarily used to treat transthyretin amyloid cardiomyopathy, a condition that affects the heart. At the molecular level, Tafamidis works by stabilizing a protein called transthyretin, preventing it from breaking apart and forming harmful deposits in the body. It is classified as a transthyretin stabilizer in pharmacology.

Investigated diseases

Transthyretin Amyloid Cardiomyopathy – Transthyretin amyloid cardiomyopathy is a condition where abnormal protein deposits, known as amyloids, accumulate in the heart tissue. This buildup can cause the heart walls to become stiff, affecting the heart's ability to pump blood effectively. Over time, the heart may struggle to maintain normal function, leading to symptoms such as fatigue, shortness of breath, and swelling in the legs. The disease progresses as more amyloid deposits form, further impairing heart function. As the condition advances, individuals may experience increased difficulty with physical activities. The progression of the disease can vary among individuals, with some experiencing a more rapid decline in heart function than others.