A Phase 1 study to evaluate the metabolism of [14C]PF-07104091 in healthy adult male participants
This early-stage study, called a Phase 1 trial, is investigating how a new medicine known as PF-07104091 is handled and broken down by the body. To do this, healthy adult men are taking part. Scientists want to understand how the body absorbs, distributes, transforms, and removes this medicine. This information is crucial for developing it further, especially as it's being explored for its potential use in treating certain cancers. These include some types of breast cancer (like HR-positive, HER2-negative, and triple-negative), non-small cell lung cancer, and ovarian cancer. This study helps lay the groundwork for future research into new cancer treatments.
At a glance
What is this study about?
This study is an early step in developing a new medicine called PF-07104091. It's what doctors call a 'Phase 1' study. The main goal of this kind of study isn't to treat illness yet, but to understand how a new medicine behaves in the human body. Think of it like learning how a car engine works before you try to drive it on complicated roads.
Specifically, this study will look at how the body processes PF-07104091. This involves carefully tracking how the medicine is absorbed after it's taken, how it travels around inside the body, how it's changed by the body's natural processes, and finally, how the body gets rid of it. Because this medicine is being developed as a potential treatment for several types of cancer, including breast cancer, lung cancer, and ovarian cancer, understanding these early steps is really important.
By gathering this information from healthy volunteers, researchers can figure out important details like the right dose to use in future studies, how often it might need to be taken, and what to expect in terms of side effects. This knowledge is vital for making sure any future studies in people with cancer are as safe and effective as possible.
Key takeaways
- This is an early-stage study (Phase 1) of a new medicine for potential cancer treatment.
- It aims to understand how the body processes the medicine.
- Only healthy adult men are included in this particular study.
- Participation helps future research for breast, lung, and ovarian cancers.
- No direct health benefits are expected for participants in this study.
Who may be eligible?
This study is looking for healthy men to take part. To be considered, you must be an adult, aged 18 years or older. There isn't an upper age limit mentioned, so older men might also be able to join.
It's important that you are in generally good health. This means you wouldn't have any serious ongoing medical conditions that could affect how the new medicine works or make taking part unsafe for you. The medical team will check your health carefully to ensure this.
Because this is an early study to understand how the medicine works in the body, it's open only to healthy men at this stage. People with the specific cancers mentioned, or women, are not included in this particular study.
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 in good health?
- Do you not have any serious ongoing medical conditions?
What does participation involve?
If you decide to take part in this study, you would first have a full health check-up to make sure you are suitable. Once confirmed, you would receive the study medicine, PF-07104091, which has been specially marked so researchers can track it in your body.
Over a period of time, you would have several visits to the clinic. During these visits, the medical team would take samples of your blood and possibly urine at various times. These samples help them understand how your body is processing the medicine. You would also have regular check-ups to monitor your general health and any effects the medicine might have.
We don't have exact details about the number of visits or the total length of the study from this summary, but typically, these early-stage studies can involve stays at a clinic for initial dosing and then follow-up appointments over several weeks. All assessments and the study medication would be provided as part of your participation.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is a 'Phase 1' study?
It's the first step where a new medicine is given to people. It mainly checks if it's safe and how the body handles it, rather than treating an illness.
Why are only men included in this study?
Sometimes early studies focus on one sex to simplify understanding how a new medicine works before expanding to wider groups.
What does a 'healthy adult' mean for this study?
It means you generally don't have any major ongoing health problems that could affect how the new medicine works or make the study unsafe for you.
Will I get paid to participate?
Study participation often includes payment for time and travel, but this specific detail would be confirmed by the study team.
What kind of cancers is this medicine being looked at for?
It's being developed for specific types of breast cancer, non-small cell lung cancer, and ovarian cancer in the future.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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