Study on the Bioavailability of Nilotinib in Healthy Individuals with Chronic Myelogenous Leukemia (CML)

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What is this study about?

This clinical trial is focused on studying the bioavailability of a medication called Nilotinib, which is used to treat a type of blood cancer known as Chronic Myelogenous Leukemia (CML). The study involves comparing different forms of Nilotinib capsules to understand how the body absorbs the medication. The trial is designed to explore the differences in how the medication is processed in the body when taken in different forms.

Participants in the study will be healthy individuals who will receive a single dose of Nilotinib in a controlled setting. The study will follow a specific plan where participants will take the medication in different sequences and periods. This approach helps researchers understand the medication’s absorption and processing in the body. The study will also include a comparison with a placebo to ensure accurate results.

The main goal of the study is to assess the safety and effectiveness of Nilotinib by monitoring participants for any side effects and measuring how the medication is absorbed. This information will help improve the understanding of Nilotinib and its use in treating Chronic Myelogenous Leukemia. Participants will be closely monitored throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, you will be required to provide free written informed consent. This means you agree to participate in the study after understanding all the procedures and requirements.

You must be willing to comply with all study procedures and restrictions, including those related to alcohol consumption, diet, exercise, contraception, and medications.

2 first study period

During the first study period, you will receive a single dose of nilotinib in the form of a 200 mg hard capsule. This medication is taken orally.

You will be part of a randomized, open-label study, meaning you will be randomly assigned to a treatment group, and both you and the researchers will know which treatment you are receiving.

3 subsequent study periods

The study involves four treatment periods, each with a single dose of the medication. You will participate in all four periods, receiving the medication in different sequences.

There will be a washout period between each treatment period to ensure the medication is cleared from your body before the next dose.

4 monitoring and assessments

Throughout the study, your health will be monitored through various assessments, including ECG (a test that measures the electrical activity of your heart), vital signs, and clinical laboratory tests.

The study will evaluate the bioavailability of the medication, which refers to how much of the drug is absorbed into your bloodstream and how long it stays there.

5 completion of the study

After completing all four treatment periods, you will have a final assessment to ensure your health and well-being.

You will be required to follow any post-study instructions provided by the research team, including any necessary follow-up appointments.

Who Can Join the Study?

Provide free written informed consent before any study procedures begin. This means you agree to participate after being fully informed about the study.
Be willing to follow all study procedures and restrictions, such as those related to alcohol, diet, exercise, contraception, and medications.
If you are a female, you must either be unable to have children or agree to use an accepted method of birth control from at least 4 weeks before the study starts until at least 1 month after the last dose of the study drug.
If you are a male and sexually active with a female partner who can have children, you must use a condom from the start of the study until at least 1 month after the last dose of the study drug.
If you are a male, ensure your female partner agrees to use a highly effective method of birth control for the same period.
If you are a male, you must agree not to donate sperm from the start of the study until at least 1 month after the last dose of the study drug.
Have a negative SARS-CoV-2 test or a valid EU Digital COVID-19 Recovery Certificate.
Be between 18 and 55 years old at the time of signing the informed consent.
Have a body weight of at least 48 kg and a body mass index (BMI) between 18.5 and 30.0 kg/m². BMI is a measure of body fat based on height and weight.
Have no significant diseases in your medical history.
Have no significant abnormalities during a physical examination.
Have no significant abnormalities on a 12-lead ECG, which is a test that checks for problems with the electrical activity of your heart.
Have no significant abnormalities in clinical laboratory tests.
Test negative for HIV (Human Immunodeficiency Virus), Hepatitis B, and Hepatitis C.
Be a non-smoker or someone who has not used tobacco or nicotine products for at least 3 months before the study.

Who Cannot Join the Study?

Patients with Primary Philadelphia-chromosome positive leukemia cells from chronic myelogenous leukemia (CML) cannot participate. This means if your leukemia cells have a specific genetic marker called the Philadelphia chromosome, you are not eligible.

Where you can join this trial?

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Site Name	City	Country	Status
Bqoxnqmnkprz Iccpldbomsqs E Darzboavmnljcqt Em Spvod Llqr	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	10.10.2022

Trial locations

Investigated drugs:

Nilotinib

Nilotinib is a medication used in this clinical trial. It is designed to treat certain types of cancer by blocking the action of a protein that signals cancer cells to multiply. In this study, the focus is on understanding how the body absorbs and processes this medication when taken as a single dose. The trial compares different versions of the medication to see if they are absorbed in the same way, which is important for ensuring that patients receive the correct amount of the drug for it to be effective.

Investigated diseases:

Philadelphia positive chronic myeloid leukaemia

Chronic Myelogenous Leukemia – Chronic Myelogenous Leukemia (CML) is a type of cancer that starts in certain blood-forming cells of the bone marrow. It is characterized by the overproduction of myeloid cells, which are a type of white blood cell. The disease progresses through three phases: chronic, accelerated, and blast crisis. In the chronic phase, symptoms may be mild or absent, and the disease progresses slowly. During the accelerated phase, the number of abnormal cells increases, and symptoms become more noticeable. The blast crisis phase resembles acute leukemia, with a rapid increase in immature white blood cells, leading to more severe symptoms.

Trial ID:

2022-501325-20-00

Protocol code:

BLCL-NIL-PIL03

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Study on the Bioavailability of Nilotinib in Healthy Individuals with Chronic Myelogenous Leukemia (CML)

What is this study about?

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Who Cannot Join the Study?