A Study in Healthy Adult Male Participants to Evaluate the Metabolism of [14C]PF-06821497
This study, called a Human Pharmacology (Phase I) study, is investigating a new medicine known as PF-06821497. The main goal is to understand how the medicine is absorbed, broken down, and leaves the body of healthy adult men. Researchers use a special, very low dose of the medicine containing a tiny amount of a marker (indicated by "[14C]") to trace its journey through the body. This information is crucial for scientists to learn more about the medicine before it can be tested in patients with conditions like small cell lung cancer, castration-resistant prostate cancer, and follicular lymphoma. It helps them figure out the best way to use the medicine in the future.
At a glance
What is this study about?
This study is an early stage of testing for a new medicine called PF-06821497. Its main purpose is to understand how your body handles this medicine. Think of it like taking a new food and trying to figure out how your body digests it, uses its nutrients, and gets rid of the waste products. For a medicine, this process is called metabolism.
Researchers want to see how the medicine is absorbed into your bloodstream, how it's broken down by your liver and other organs, and how it eventually leaves your body, for example, through urine or faeces. To do this, they use a very small, safe amount of the medicine that has a special marker, often called a 'tracer.' This tracer helps them track the medicine's path and see where it goes in your body. This particular study is in healthy adult men, which helps them understand the basic behaviour of the drug without the complications of different health conditions.
The information gathered from this study is really important. It helps scientists learn vital details about the medicine, such as how quickly it works, how long it stays in the body, and how much of it is needed to have an effect. This foundational knowledge is crucial before the medicine can be tested in people who actually have the illnesses it aims to treat, like small cell lung cancer, a type of prostate cancer, or follicular lymphoma. It's a key step in developing new and effective treatments.
Key takeaways
- This is an early study of a new medicine for cancer.
- It aims to understand how the medicine is processed by the body.
- Only healthy adult men aged 18 and over can participate.
- Participation helps scientists learn crucial information for future treatments.
- Your health will be carefully monitored throughout the study.
Who may be eligible?
This study is looking for participants who are healthy adult men. You must be at least 18 years old to take part, and there's no upper age limit specified, as long as you are considered generally healthy. Being 'healthy' means you don't have any significant ongoing medical conditions that could affect how your body handles the study medicine or might make participating unsafe.
To ensure your safety and that the study results are clear, doctors will conduct health checks before you can join. This might include reviewing your medical history, asking about any medicines you currently take, and performing some examinations or tests. This careful screening helps make sure the study includes only those who are a good fit.
- Are you male?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you willing to undergo health checks to confirm your suitability?
- Are you able to attend appointments at a study clinic?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive a single dose of the study medicine. Before and after taking the medicine, you'd have several visits to the study clinic. These visits would involve various assessments, such as blood and urine tests, to help researchers track how your body processes the medicine. You might also have regular check-ups to monitor your general health.
The total duration of your participation, including all visits and follow-up, would be explained in detail before you agree to join. You might need to stay at a clinic for a short period after receiving the medicine, or attend several outpatient appointments over a few days or weeks. All specific details would be provided to you.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is a 'Phase I' study?
It's an early stage of testing for a new medicine, usually involving a small group of healthy people to understand how the medicine behaves in the body and if it's safe.
Why use healthy men for this study?
Using healthy men helps researchers understand how the medicine works in a typical body without other health conditions affecting the results, giving a clear picture of its basic actions.
What does '[14C]' mean on the medicine name?
It means the medicine has a tiny, safe marker (like a postcode) attached to it. This allows scientists to easily track its journey through your body using special equipment.
Will this medicine help treat my cancer?
No, this study is about understanding the medicine's basic actions in healthy people. It's not a treatment for cancer at this stage.
What is 'metabolism' in this study?
Metabolism refers to how your body takes in the medicine, breaks it down, uses it, and gets rid of it. This study wants to understand that process.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.