Not recruiting

A study to evaluate how the body processes zipalertinib in healthy adult men

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates how the body processes a new experimental drug called [14C]-zipalertinib, which is being studied for the treatment of Cancer. The purpose of the study is to understand the pharmacokinetics, which refers to how a drug moves through the body, and the metabolism, which is the process by which the body breaks down a substance. Researchers will also look at the mass balance to determine how much of the drug is eliminated from the body through urine and feces.

During the study, healthy adult males will receive a single dose of [14C]-zipalertinib in the form of an oral suspension, which is a liquid medicine taken by mouth. After taking the dose, participants will provide samples of plasma, which is the liquid part of the blood, and whole blood to measure the concentration of the drug. Additionally, samples of urine and feces will be collected to track how the substance is cleared from the system.

The research involves monitoring how the drug is distributed and how it changes over time within the body. Scientists will examine the levels of the drug in different biological fluids to create a complete profile of its behavior. This information helps in understanding how the medicine might eventually be used to treat patients safely and effectively.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of the test substance
A single dose of 100 mg of zipalertinib, provided as an oral suspension (a liquid containing medicine particles), is taken by mouth.
This substance contains a special marker called 14C, which is used to track how the body processes the medication.
Step 2
Monitoring and collection
Blood and plasma (the liquid part of the blood) are collected to measure the levels of the medication and how it moves through the body.
urine and feces (stool) samples are collected to determine how much of the medication is eliminated from the body.
vital signs, such as heart rate and blood pressure, are measured.
An electrocardiogram (an assessment of heart activity) is performed.
physical examinations and clinical laboratory tests are conducted to monitor for any side effects or changes in health.

Who can join the trial?

11 criteria

You must be a male.
You must be between 18 and 67 years old at the time of the initial screening.
You must be in good physical and mental health, as confirmed by your medical history, a physical exam, blood tests, an electrocardiogram (a test that records the electrical activity of your heart), and your vital signs (such as blood pressure and pulse).
Your body mass index (a measure used to determine if your weight is healthy for your height) must be between 18.0 and 32.0 kg/m2.
You must be willing and able to sign the informed consent form, which is a document explaining all details of the study before you agree to join.
If you have not had a vasectomy (a surgical procedure for men that prevents pregnancy) at least 4 months before the study, you must agree to use effective contraception (methods used to prevent pregnancy, such as condoms or hormonal methods) and not donate sperm until 90 days after the end of the study.
You must stop taking all prescribed medications, over-the-counter medicines, vitamins, food supplements, or herbal products at least 14 days before arriving at the center, except for paracetamol (a common pain reliever), which is allowed in limited amounts.
You must stop taking any medicines that affect cytochrome P450 (CYP)3A enzymes or P-glycoprotein (proteins in the body that help process and move drugs) at least 28 days before the study. This includes products like St. John's Wort.
You must be able and willing to avoid alcohol for 48 hours before your screening and stay away from it until you are discharged from the center.
You must be able to fast (not eat anything) for at least 14 hours during the study period.
You must avoid foods and drinks containing methylxanthines (substances found in coffee, tea, cola, chocolate, and energy drinks) and grapefruit or grapefruit juice for 48 hours before arriving at the center.

Who cannot join the trial?

20 criteria

You are an employee of the company running the study or the company sponsoring the research.
You have been exposed to radiation (energy that can damage cells, such as X-rays) for medical reasons, work, or other studies in the last year, except for dental X-rays or simple X-rays of the chest and bones.
You have had unusual bowel movements (pooping habits), such as diarrhea (very loose or watery stools) or constipation (difficulty passing stool or going less than once every two days), within the last 2 weeks.
You tested positive for Hepatitis B, Hepatitis C, or HIV (viruses that affect the liver or the body's immune system) during your screening.
You have taken part in another drug study within the last 30 days, or you have participated in 4 or more drug studies in the last 12 months.
You have donated or lost more than 450 mL of blood within the last 60 days.
You have donated plasma (the liquid part of the blood) within the last 7 days.
You have had a significant or sudden illness in the last 5 days that might affect safety checks.
Your veins are not suitable for drawing blood samples.
You have a history of allergies (bad reactions) to certain drugs or foods.
You have used tobacco products within the last 30 days.
You have a history of alcohol abuse or addiction to drugs, including cannabis (marijuana), within the last 2 years.
You test positive for drugs or alcohol (including substances like cocaine, amphetamines, or nicotine) during screening or when entering the research center.
You drink more than 24 units of alcohol per week.
You have a history of hypersensitivity (an extreme allergic reaction) to the study drug or similar medicines.
You have heart problems, such as ventricular dysfunction (the heart's lower chambers not pumping well), heart failure, or a family history of Long QT Syndrome (a condition that affects the heart's electrical rhythm).
Your heart shows a specific electrical pattern called a QTcF greater than 470 ms, which relates to how your heart beats.
You cannot swallow pills or take medicine by mouth due to medical conditions or past surgeries that affect your gastrointestinal function (how your stomach and intestines work), such as Crohn's disease, ulcerative colitis (diseases that cause swelling in the digestive tract), or malabsorption syndrome (when the body cannot properly soak up nutrients from food).
You have had surgeries like a gastrectomy (removal of part of the stomach) or colectomy (removal of part of the large intestine).
You have participated in other studies involving radiation burden (the amount of radiation your body absorbs) within specific timeframes over the last few years.

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Verified sites

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Pharmaceutical Research Associates Group B.V.
Verified
Groningen, The Netherlands

Trial locations

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Investigated drugs

Zipalertinib is an experimental medication being studied to understand how it is absorbed, how it moves through the body, and how it is broken down and eliminated after being taken by mouth.

[14C]ZIPALERTINIB

What is already known about the treatment

[14C]zipalertinib - This medication is taken orally in the form of a liquid suspension. It is currently an experimental drug being studied in clinical trials to understand how the body processes it. It is being developed as a potential treatment for various types of cancer by targeting specific proteins that help cancer cells grow. As a targeted therapy, it works at a molecular level to block the signals that tell cancer cells to multiply, effectively slowing down the disease.

Investigated diseases

Cancer - This condition occurs when abnormal cells in the body grow and divide uncontrollably. These cells can form masses known as tumors in various parts of the body. As the disease progresses, these abnormal cells may spread to nearby tissues or distant organs. This process can disrupt the normal functions of the affected biological systems. The growth of these cells typically happens over an extended period.