Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A PHASE 1 STUDY TO ASSESS THE MASS BALANCE, PHARMACOKINETICS, AND METABOLISM OF ORAL [14C]-ZIPALERTINIB IN HEALTHY ADULT MALE SUBJECTS

This is a very early study (Phase 1) focused on understanding how a new medicine, called [14C]-zipalertinib, works inside the bodies of healthy adult men. The main goal is to see how much of the drug is absorbed, how it's processed and broken down, and how it eventually leaves the body (this is called 'mass balance' and 'pharmacokinetics'). Researchers will be giving a small, traceable amount of the drug and then carefully measuring its levels and changes in blood, urine, and stool over time. We'll also be closely monitoring for any potential side effects to make sure it's safe. This information is crucial for developing the drug further for people with cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Taiho Oncology Inc.

Enrolment target

Start

09 Jun 2023

Cancer

What is this study about?

Imagine your body as a very complicated machine. When you take a new medicine, your body starts to process it. This study, which is a very early step in developing a new medicine for cancer, aims to understand exactly what happens to this particular drug, called zipalertinib, once a person takes it.

Researchers will give a tiny, specially marked dose of zipalertinib (the '14C' means it's radioactive, but don't worry, it's a very small, safe amount that helps us track it). They will then carefully measure how much of this drug, and any substances it changes into, is in the blood, urine, and stool over time. This helps them learn how the body absorbs the medicine, how quickly it starts working, how it's broken down, and how long it takes for it to leave the body. This is important information for deciding the right dose and how often it needs to be taken.

Because this is a new medicine, the study will also pay close attention to any possible side effects or changes in health that participants might experience. This information is vital to make sure the drug is safe before it can be tested in patients who have cancer. This kind of study helps us learn the basic facts about a new medicine so it can be developed safely and effectively for future patients.

Key takeaways

This is an early-stage study (Phase 1) for a new cancer drug called zipalertinib.
It aims to understand how a healthy body absorbs, changes, and removes the drug.
Only healthy adult men aged 18 and over are eligible.
Participation involves taking a single dose of the drug and having regular blood, urine, and stool tests.
Your health will be closely monitored for safety throughout the study.
This study helps gather basic information crucial for developing future cancer treatments.

Who may be eligible?

This study is specifically looking for healthy adult men to take part. To be eligible, you need to be at least 18 years old.

Because this is an early study to understand how the body handles the medicine, and not to treat a condition, only healthy individuals are being sought. This helps researchers get clear information without other health issues complicating the results.

They are only including men in this particular study. Other studies might include women or people with cancer once more is known about the drug's safety and how it works.

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 male?
Are you 18 years old or older?
Are you generally healthy?
Do you understand this is not a cancer treatment study?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive a single dose of the study medicine, [14C]-zipalertinib. Because the medicine is designed to be traced in your body, researchers will collect regular samples of your blood, urine, and stool over a period of time. This is how they measure how the drug is moving through and leaving your body. You may need to stay at a research clinic for some of this time so that these samples can be collected accurately.

Throughout the study, your health will be carefully monitored. This includes checking your vital signs (like blood pressure and heart rate), performing physical examinations, taking electrocardiograms (ECGs) to check your heart, and doing routine blood and urine tests. This is to make sure you remain healthy and to identify any potential side effects. The exact number of visits, tests, and the total length of your participation would be explained in detail by the study team.

Potential risks and benefits

Participating in research studies like this can help advance medical knowledge, potentially leading to new treatments for serious diseases like cancer. You would also receive close medical attention and monitoring. However, as with any medicine, there's always a possibility of experiencing side effects, some of which might be unknown at this early stage. You would be fully informed about all known risks before deciding to participate. Remember, taking part in a clinical trial is always voluntary, 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.

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Unverified
Netherlands

Common questions

Why are only healthy men being asked to participate?

This early study aims to understand how the drug works in a healthy body without other health conditions making it harder to get clear results. Further studies will involve women and patients with cancer.

What does '[14C]' mean on the drug name?

It means the drug has a tiny, safe, and traceable marker. This allows researchers to follow the drug's path through your body very precisely using special tests.

Will I get cancer treatment by joining this study?

No, this is not a treatment study. It's an early safety and understanding study for a new drug. Participants must be healthy and do not have cancer.

What kind of tests will I have?

You'll have regular blood, urine, and stool sample collections, as well as checks on your heart (ECG), blood pressure, and general health examinations.

How long will I need to be involved?

The exact duration will be explained by the study team, but typically these types of studies involve a period of close monitoring after taking the single dose of medication.