A study to evaluate how lazertinib is absorbed in healthy adults to support future treatment for non-small cell lung cancer.

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What is this study about?

This study focuses on Non-small cell lung cancer, which is a common type of lung cancer. The research involves testing a medication called lazertinib, also known by its code name JNJ-73841937. The purpose of the study is to compare how much of the drug enters the bloodstream when taken in different tablet forms. This process is known as bioavailability, which refers to the amount of a substance that reaches the circulation to have an effect on the body.

The study is conducted using oral use, meaning the medication is taken by mouth in the form of a tablet. Participants will receive a single dose of 240 mg of the medication while in a fasted state, which means they have not eaten for a certain period before taking the drug. The study follows a crossover design, where participants receive different versions of the medication at different times to allow for direct comparison.

Who Can Join the Study?

You must be a healthy adult, meaning you do not have any existing medical conditions being studied.
You must be between 18 and 60 years old.
Your body mass index, which is a measure used to determine if a person has a healthy weight for their height, must be between 19.0 and 30.0.
Your body weight must be at least 50.0 kilograms.
You can be either male or female.

Who Cannot Join the Study?

A history of or current significant medical illness, such as cardiac arrhythmias (irregular heartbeats) or other heart diseases.
Having hematologic disease (diseases affecting the blood) or coagulation disorders (problems with how your blood clots, including abnormal bleeding).
Having lipid abnormalities (unhealthy levels of fats, such as cholesterol, in the blood).
Significant lung problems, including bronchospastic respiratory disease (conditions like asthma where airways narrow) or interstitial lung disease (scarring of the lung tissue).
Having diabetes mellitus (high blood sugar), though a history of gestational diabetes (diabetes during pregnancy) is allowed.
Having hepatic insufficiency (a condition where the liver cannot function properly).
Having inflammatory bowel disease, such as Crohn’s disease (a condition causing inflammation in the digestive tract).
Having thyroid disease (problems with the gland that controls metabolism), neurologic disease (conditions affecting the brain or nerves), or psychiatric disease (mental health conditions).
Having any current infection.
A history of COVID-19 infection within 4 weeks before the first dose, or having ongoing symptoms or testing positive for the virus.
A history of stomach or intestinal surgery, including cholecystectomy (surgical removal of the gallbladder), that could change how the body absorbs or gets rid of medicine.
A history of malignancy (cancer) within the last 5 years, except for certain skin cancers or specific types of cervical cancer that are considered cured.
Known allergies, hypersensitivity (an exaggerated immune response), or intolerance to lazertinib (the study drug) or its excipients (inactive ingredients used to make the medicine).
A history of significant drug allergies, though allergies to pollen (allergic rhinitis) or food are allowed.
Any health condition that the researcher believes would be unsafe for you or could interfere with the study results.
Having had major surgery requiring general anesthesia (medicine that puts you to sleep) within 8 weeks before the study, or having surgery planned during the study period.
Taking any medicines that are not allowed by the study rules.
Using any prescription drugs, over-the-counter medicines, vitamins, or herbal supplements within 14 days of the study, except for paracetamol, ibuprofen, or stable hormone replacement therapy (for postmenopausal women).
Having recently taken an investigational intervention (an experimental medicine or vaccine) or used an experimental medical device within a specific timeframe.
Testing positive for Hepatitis A, Hepatitis B, or HCV (Hepatitis C virus) during screening.
A history of or testing positive for HIV (Human Immunodeficiency Virus).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
SGS Belgium	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	25.05.2023

Trial locations

Investigated drugs:

Lazertinib

Lazertinib is an experimental medication being tested in this study to see how well the body absorbs different tablet versions of the drug when taken by mouth.

Investigated diseases:

Non-small cell lung cancer

Non-small cell lung cancer – This is a type of lung cancer that begins in the cells lining the inside of the lungs. It typically starts in the cells that produce mucus. The disease often begins as a small growth that can expand within the lung tissue. As it progresses, these abnormal cells may spread to nearby parts of the lung or other areas of the body. It is the most common form of lung cancer found in adults.

Trial ID:

2022-502814-99-00

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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A study to evaluate how lazertinib is absorbed in healthy adults to support future treatment for non-small cell lung cancer.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?