A study comparing how lenvatinib capsules are absorbed in the body in healthy volunteers under fasting and fed conditions

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What is this study about?

This study examines Lenvatinib, a medication used to treat several types of cancer. The study focuses on three specific conditions: advanced or recurrent endometrial carcinoma, which is a cancer of the lining of the uterus in adults whose disease has worsened after previous treatment with platinum-based therapy and who cannot be treated with surgery or radiation; progressive, locally advanced or spread out differentiated thyroid carcinoma, which includes papillary, follicular, and Hurthle cell types that no longer respond to radioactive iodine treatment in adults; and advanced or inoperable hepatocellular carcinoma, which is a type of liver cancer in adults who have not received any previous systemic therapy. The medication being tested comes in capsule form and is taken by mouth.

The purpose of this study is to compare how the body absorbs different versions of Lenvatinib 10 mg capsules, including two test products and one reference product, when taken both with and without food. The study will measure how much of the medication enters the bloodstream and how long it stays in the body. This is done by looking at the highest level of medication in the blood, when this highest level occurs, and the total amount of medication in the blood over time. The study will also evaluate safety by monitoring any unwanted effects, heart activity through electrical recordings, vital signs like blood pressure and heart rate, and laboratory test results.

The study involves healthy volunteers who will receive single doses of the medication in different treatment periods. Participants will take each version of the capsule at different times, with breaks between treatments, to allow comparison of how each version works in the body. The study design allows each person to receive all three treatments in a specific order, with some participants taking the medication without food and others taking it with food. Blood samples will be collected to measure the levels of medication, and participants will be monitored throughout the study for any changes in their health.

1 Informed consent and screening

Before any study procedures begin, you will provide written informed consent, confirming your voluntary participation in this research.

You will undergo screening procedures to determine if you meet the study requirements. This includes a test for SARS-CoV-2 or presentation of a valid EU Digital COVID-19 Recovery Certificate.

Your medical history will be reviewed to ensure no significant health conditions are present.

A physical examination will be performed to check your overall health status.

A 12-lead ECG (a test that records the electrical activity of your heart) will be conducted to ensure no abnormalities are present.

Blood and laboratory tests will be performed, including tests for HIV antibodies, Hepatitis B surface antigen, and Hepatitis C antibodies to confirm you do not have these infections.

Your body mass index (a measure of body fat based on height and weight) will be calculated and must be between 18.5 and 30.0 kg/m2.

2 Preparation period

If you are female and of childbearing potential, you must use an accepted method of contraception starting at least 4 weeks before the first dose of study medication.

If you are male and sexually active with a female partner, you must use a condom starting from the first study period.

You must not donate sperm during this time if you are male.

3 First treatment period

You will be admitted to the study facility for the first treatment period.

You will receive a single dose of Lenvatinib 10 mg capsule by mouth. The specific product (Test-1, Test-2, or Reference) will be assigned randomly according to the study design.

Depending on your assigned group, you may receive the medication under fasting conditions (without food) or fed conditions (after a meal).

Blood samples will be collected at specific times after dosing to measure the amount of medication in your bloodstream. Samples will be taken up to 72 hours after you receive the dose.

Your safety will be monitored throughout this period through assessment of any adverse events (unwanted or harmful effects), ECG, vital signs (such as blood pressure and heart rate), and clinical laboratory tests.

4 Washout period after first treatment

After completing the first treatment period, there will be a break before the next treatment period. This allows the medication to be eliminated from your body.

5 Second treatment period

You will be admitted to the study facility for the second treatment period.

You will receive a single dose of Lenvatinib 10 mg capsule by mouth. You will receive a different product than in the first period, as determined by the randomization sequence.

The medication will be given under either fasting or fed conditions, depending on your assigned sequence.

Blood samples will be collected at specific times after dosing to measure the amount of medication in your bloodstream. Samples will be taken up to 72 hours after you receive the dose.

Your safety will be monitored through assessment of any adverse events, ECG, vital signs, and clinical laboratory tests.

6 Washout period after second treatment

After completing the second treatment period, there will be another break before the third treatment period to allow the medication to be eliminated from your body.

7 Third treatment period

You will be admitted to the study facility for the third treatment period.

You will receive a single dose of Lenvatinib 10 mg capsule by mouth. You will receive the remaining product that you have not yet received, as determined by the randomization sequence.

The medication will be given under either fasting or fed conditions, depending on your assigned sequence.

Blood samples will be collected at specific times after dosing to measure the amount of medication in your bloodstream. Samples will be taken up to 72 hours after you receive the dose.

Your safety will be monitored through assessment of any adverse events, ECG, vital signs, and clinical laboratory tests.

8 Final follow-up

After completing all three treatment periods, your participation in the study will conclude.

If you are female of childbearing potential, you must continue using contraception for at least 4 weeks after receiving the last dose of study medication.

If you are male and sexually active, you must continue using a condom for at least 4 weeks after receiving the last dose of study medication.

If you are male, you must not donate sperm for 4 weeks following the last dose of study medication.

Who Can Join the Study?

You must provide written permission to take part in the study before any study procedures begin
You must be willing to follow all study rules and requirements
If you are a woman, you must either be unable to have children, or if you can have children, you must agree to use birth control (a method to prevent pregnancy) starting at least 4 weeks before the study begins and continuing until at least 4 weeks after taking the last dose of the study medicine
If you are a man who is sexually active with a woman who can have children, you must use a condom (a barrier method of birth control) from the start of the study until at least 4 weeks after taking the last dose of the study medicine
If you are a man, you must agree not to donate sperm from the start of the study until 4 weeks after taking the last dose of the study medicine
You must have a negative test result for SARS-CoV-2 (the virus that causes COVID-19) or have a valid recovery certificate showing you have recovered from COVID-19
You must be between 18 and 55 years old at the time you sign the permission form
Your body mass index (a measure of body fat based on your height and weight) must be between 18.5 and 30.0
You must not have any significant diseases in your medical history that could affect the study
Your physical examination must not show any significant health problems
Your ECG (a test that measures the electrical activity of your heart) must not show any significant abnormalities
Your blood and urine tests must not show any significant abnormalities
You must have negative test results for HIV (a virus that affects the immune system), Hepatitis B (a liver infection), and Hepatitis C (another liver infection)
You must be a non-smoker or have stopped using tobacco or nicotine products for at least 3 months before the screening visit

Who Cannot Join the Study?

You cannot participate if you have a known allergy (severe reaction) to the study medicine or any of its ingredients
You cannot participate if you are pregnant or breastfeeding (nursing a baby)
You cannot participate if you have severe liver problems (your liver is not working properly)
You cannot participate if you have severe kidney problems (your kidneys are not working properly)
You cannot participate if you have uncontrolled high blood pressure (blood pressure that cannot be managed with medicine)
You cannot participate if you have had a recent heart attack (damage to your heart muscle) or stroke (blocked blood flow to the brain)
You cannot participate if you have active bleeding or a high risk of serious bleeding
You cannot participate if you are taking certain medicines that may interact badly with the study medicine
You cannot participate if you have another active cancer (different from the one being studied) that requires treatment
You cannot participate if you have an active serious infection that is not controlled
You cannot participate if you have had major surgery (a large operation) within a certain time before the study starts
You cannot participate if you are unable to swallow pills or have problems with your digestive system (stomach and intestines) that would prevent you from absorbing the medicine properly

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Berrhycadyej Iukjdtyuombs E Dkfowfsutsgsqqa Ew Shont Lyco	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	06.03.2023

Trial locations

Investigated drugs:

Lenvatinib

Lenvatinib is a cancer medication that works by blocking certain proteins that help cancer cells grow and spread. In this study, it is being tested to compare how the body absorbs different versions of the same medicine when taken with or without food.

Investigated diseases:

Endometrial Carcinoma – Endometrial carcinoma is a type of cancer that begins in the lining of the uterus, called the endometrium. It typically starts when cells in the endometrium begin to grow abnormally and form a tumor. As the disease progresses, cancer cells may invade deeper layers of the uterine wall. In advanced stages, the cancer can spread beyond the uterus to nearby organs or distant parts of the body. The disease may recur after initial treatment, meaning it comes back after a period of improvement. When endometrial carcinoma advances or recurs, it becomes more difficult to manage with local treatments alone.

Differentiated Thyroid Carcinoma – Differentiated thyroid carcinoma is a cancer that develops in the thyroid gland, a small organ located in the front of the neck. This type includes papillary, follicular, and Hurthle cell cancers, which are named based on how the cancer cells appear under a microscope. These cancers typically grow slowly and often respond well to treatment in early stages. However, in some cases, the cancer progresses and spreads to nearby tissues or distant organs in the body. The disease is considered locally advanced when it grows into structures near the thyroid, and metastatic when it spreads to distant body parts. Some thyroid cancers become refractory to radioactive iodine, meaning they no longer respond to this common treatment approach.

Hepatocellular Carcinoma – Hepatocellular carcinoma is the most common type of primary liver cancer, originating in the main cells of the liver called hepatocytes. This cancer often develops in people who have chronic liver disease or damage to the liver over many years. As the tumor grows, it can affect liver function and may spread to other parts of the liver or beyond. The disease is considered advanced when the cancer has grown extensively or spread to other organs. When the tumor cannot be removed by surgery, it is described as unresectable. Hepatocellular carcinoma can progress rapidly and significantly impact the body’s ability to perform essential functions.

Trial ID:

2022-501327-25-00

Protocol code:

BLCL-LEN-PIL01

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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A study comparing how lenvatinib capsules are absorbed in the body in healthy volunteers under fasting and fed conditions

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?