Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Comparative Bioavailability of Lenvatinib 10 mg Capsules: A Two-Part, Single-Dose, Open-Label, Randomized, Six-Sequence, Three-Treatment, Three-Period, Crossover Pilot Study in Healthy Subjects Under Fasting and Fed Conditions.

This research is investigating a cancer medication called Lenvatinib. The main goal is to compare how well different forms of the Lenvatinib 10 mg capsule are absorbed by the body. This is important to make sure that patients always receive a consistent and effective dose of their medicine. We'll be looking at how the body processes the medication, both when someone has eaten and when they haven't. This is a very early-stage study, involving healthy adult volunteers, rather than people who are ill. By understanding how the drug behaves in the body, we can help ensure it's used as effectively as possible for people with certain advanced cancers, such as specific types of thyroid, liver, or endometrial cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

03 Mar 2023

What is this study about?

This study is designed to understand how your body handles a medicine called Lenvatinib. Lenvatinib is a treatment used for certain types of advanced cancers, including some kinds of thyroid cancer, liver cancer, and a type of womb cancer called endometrial carcinoma, especially when other treatments haven't worked or can't be used.

The main purpose of this study is to compare how readily and quickly Lenvatinib is absorbed into the bloodstream. We're looking at different versions of the 10 mg capsule to see if they deliver the medicine to your body in the same way. We also want to find out if eating food affects how your body takes in the drug – sometimes medicines are absorbed differently on an empty stomach compared to after a meal.

This kind of research is really important because it helps scientists and doctors make sure that patients always get a consistent and safe amount of medication. It's a key step in developing and approving medicines, ensuring they are reliable for everyone who needs them.

Key takeaways

This study investigates how the cancer drug Lenvatinib is absorbed by the body.
It aims to compare different forms of the drug and see if food affects absorption.
Healthy adult volunteers are needed for this early-stage research.
Participation involves taking the drug, blood tests, and health checks over several visits.
Your involvement helps improve drug development for future cancer patients.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to adults aged 18 and over. Both men and women can take part. You don't need to have cancer to participate in this particular study, as it's designed to understand how the drug works in healthy people.

It's crucial that you are generally healthy and don't have any serious medical conditions that could affect how your body handles the medicine or make taking part unsafe for you. Before you can join, the study doctors will carry out a full health check to ensure it's suitable.

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 healthy, without serious ongoing health problems?
Are you able to attend all clinic visits as required?
Are you comfortable with regular blood tests and other health checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the Lenvatinib medicine on a few separate occasions. Sometimes you'll take it after not eating for a while (fasting), and other times after having a meal. Over several visits, probably lasting a couple of days each, we will take blood samples regularly to measure how much of the drug is in your system. We will also monitor your overall health through things like heart tracings (ECGs), checking your blood pressure and pulse, and doing standard blood tests. The total duration of your involvement will include these study periods and follow-up checks, which will be fully explained before you agree to take part.

Potential risks and benefits

Taking part in any study has potential risks and benefits. There's no direct health benefit to you from participating in this specific study, as it's for research and not a treatment itself. However, your contribution will help improve our understanding of Lenvatinib, potentially benefiting future cancer patients. Potential risks include side effects from the medication, which will be closely monitored, and discomfort from blood draws. You will have a medical team looking after you throughout, and you are free to withdraw from the study at any time, for any reason, without it affecting your future 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
Portugal

Common questions

What is Lenvatinib used for?

Lenvatinib is a medicine used to treat certain types of advanced cancers, such as specific thyroid, liver, and some endometrial (womb) cancers.

Do I need to have cancer to join this study?

No, this specific study is looking at how the drug works in healthy people, so you don't need to have cancer to take part.

Will I have to stay overnight for the study?

The study involves several separate visits, some of which might require an overnight stay or extended time at the clinic. This will be fully explained.

What kind of tests will I have?

You will have regular blood tests, heart checks (ECGs), and your blood pressure and pulse will be monitored. These are standard checks to ensure your safety.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.