Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Phase 1, Open-label, Randomized, 2-Part, 2-Way Crossover Study in Healthy Adult Participants to Assess the Relative Bioavailability of Tablet Formulations of Lazertinib (JNJ-73841937)

This clinical trial is a very early-stage study involving healthy adult volunteers. It's called a 'bioequivalence study' and its main goal is to compare two slightly different tablet forms of a new medicine called Lazertinib (also known as JNJ-73841937). The researchers want to see if the body absorbs both versions of the tablet in the same way and to the same extent. Understanding how the body processes the medication is crucial when developing new treatments, especially for conditions like non-small cell lung cancer. This study helps ensure that when Lazertinib is eventually given to patients, it will be delivered effectively and consistently.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Janssen - Cilag International

Enrolment target

Start

05 Apr 2023

Non-small cell lung cancer (NSCLC)

What is this study about?

This study is an important first step in developing a new medicine called Lazertinib. Even though this medicine is being developed to treat a form of lung cancer called non-small cell lung cancer, this particular study is *not* for people with cancer. Instead, it involves healthy adults.

The main purpose of this study is to compare two different ways the Lazertinib medicine is made into a tablet. Think of it like comparing two slightly different recipes for the same cake – they might taste similar, but the ingredients or how they're mixed could be a little different. Scientists need to know if these small differences change how your body takes in the medicine. This is crucial for making sure that once the medicine is ready for patients, it will work consistently and reliably.

By carefully checking how much of the medicine gets into the bloodstream and how quickly, researchers can choose the best tablet version going forward. This helps ensure that patients who might need Lazertinib in the future get the most effective and safe treatment possible.

Key takeaways

This is an early-stage study for a new lung cancer drug, but for healthy adults.
It compares two tablet forms of the drug to see how they're absorbed by the body.
The study helps ensure the medicine will be effective and consistent for future patients.
No direct health benefit for participants.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part.

Because this is a very early-stage study to understand how a new medicine works in the body, it's designed for people who are generally well. This helps researchers get a clear picture of how the drug behaves without other health conditions affecting the results.

There will be other, more detailed entry requirements that the study team will discuss with you. These could include things like your weight, any other medicines you take, or certain health checks. They'll ensure the study is safe for you to participate in.

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 commit to several study visits?
Are you willing to have blood samples taken?
Do you understand this study is not a treatment for an illness you might have?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given two different versions of the Lazertinib tablet at different times. This study is designed so that both versions are given to you, but the order might be different from other participants. You'll have regular appointments where study staff will check your health, ask about any side effects, and take blood samples to measure how the medicine is moving through your body. The total length of your involvement in the study will be explained in detail by the research team, including how many visits you'll need to make.

Potential risks and benefits

Potential benefits of taking part include contributing valuable information that could help develop new treatments for people with non-small cell lung cancer. However, there is no direct personal health benefit from participating. Potential risks might include discomfort from blood draws, or experiencing side effects from the study medication, though these are typically monitored very closely. You should always feel free to ask questions, and 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.

—
Unverified
Belgium

Common questions

What is 'bioequivalence'?

It means checking if two different versions of the same medicine are absorbed by your body in the same way and to the same amount.

Why is this study for healthy adults, not people with cancer?

Because it's an early-stage study to understand how the drug works in a typical body, before testing it in people who are unwell.

Will I get 'Lazertinib' if I join?

Yes, you will receive two different tablet versions of Lazertinib during the study, but for research purposes only.

What is 'Non-small cell lung cancer'?

It's a common type of lung cancer. This drug is being developed to treat it, but this study won't treat your cancer if you had it.

How long will I be in the study for?

The study team will explain the exact duration and number of visits required if you are interested in taking part.