AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed by the Body in Men With Prostate Cancer

This research is looking at how specific drugs used to treat prostate cancer, such as enzalutamide, apalutamide, and bicalutamide, interact with a new medicine called fezolinetant. Fezolinetant is being developed to treat hot flushes, a common and often uncomfortable symptom. The main goal of the study is to understand how these prostate cancer medications might affect the way fezolinetant is processed and used by the body. This is a very early-stage study, meaning it's one of the first times fezolinetant is being tested with these other drugs. Understanding these interactions is important to ensure new treatments can be given safely and effectively to patients who need them.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Astellas Pharma Global Development Inc.

Enrolment target

Start

03 Apr 2026

Hot Flush

What is this study about?

This study is designed to explore how three common prostate cancer medications – enzalutamide, apalutamide, and bicalutamide – might affect a new drug called fezolinetant. Fezolinetant is currently being developed as a potential treatment for hot flushes. Hot flushes are sudden feelings of intense heat, often with sweating, that can be a side effect of some prostate cancer treatments, and they can be very bothersome.

The main purpose of this research is to see if, and how, the prostate cancer medicines change the way fezolinetant is handled by your body. This includes understanding how your body absorbs, breaks down, and gets rid of fezolinetant when you are also taking one of the prostate cancer drugs. This is important information because it helps doctors understand if the drugs can be taken together safely and if each drug will work as expected.

This is generally considered a very early-stage (Phase 1) study, often called a 'Human Pharmacology' study. This typically means researchers are focusing on understanding the basic behaviour of the drugs in the body, rather than how well they treat a disease directly. The knowledge gained from studies like this is crucial for the safe development of new medicines and for ensuring that patients receive the most effective treatment combinations.

Key takeaways

This study looks at how prostate cancer drugs might affect a new hot flush medicine.
It's an early-stage study to understand how drugs interact in the body.
It involves men who are 18 years or older.
The goal is to ensure safe and effective use of future treatments.
Participation would involve study visits and medical tests.

Who may be eligible?

To be able to join this study, people generally need to be an adult male, aged 18 years or older. There isn't an upper age limit mentioned, so older men might also be able to take part.

Because this study is looking at how certain prostate cancer drugs affect a new medicine, it's likely they will be looking for men who are already taking or have taken these specific prostate cancer treatments. However, the raw information doesn't give full details on this. Usually, studies also have other health requirements or exclude those with certain conditions to ensure safety.

If you're a man who experiences hot flushes and is taking or has taken one of the mentioned prostate cancer medications, and you're interested in research, it would be a good idea to discuss this study with your doctor. They will have all the detailed criteria to confirm if you might be suitable.

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 a man?
Are you 18 years old or older?
Do you already take (or have you taken) enzalutamide, apalutamide, or bicalutamide for prostate cancer?
Are you interested in helping research into new drug interactions?

Answer every question to see your result.

What does participation involve?

Taking part in a study like this typically involves a screening visit to check if you meet all the requirements. If you qualify, you would then attend several study visits where you might receive the study drugs. During these visits, researchers will likely collect blood or urine samples to see how the drugs are working in your body and how they interact. You may also have regular health checks and tests. The total time you spend in the study, and how many visits are needed, would be fully explained to you before you agree to take part.

Potential risks and benefits

Potential benefits of participating could include contributing to medical knowledge that might help other patients with prostate cancer and hot flushes in the future. You would also have careful monitoring of your health during the study. Potential risks could include side effects from the study drugs, which would be fully explained before you agree to take part. There's also the chance the new drug may not work for you. You are free to withdraw from the study at any time and for any reason, without it affecting your usual 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
Bulgaria

Common questions

What are hot flushes?

Hot flushes are sudden, intense feelings of warmth, often with sweating, that can be a side effect of some medical treatments, including certain prostate cancer therapies.

What is fezolinetant?

Fezolinetant is a medication that is currently being developed and tested to help treat hot flushes.

What does 'Human Pharmacology (Phase I)' mean?

It means this is a very early stage of testing new drugs. Researchers are mainly trying to understand how the drug works in the body and if it's safe, rather than how well it treats a condition.

Why is it important to study drug interactions?

It's important to understand how different drugs affect each other so doctors can prescribe them safely and ensure they work as intended, without causing unexpected side effects or reducing their effectiveness.

Will I get paid to participate?

Sometimes studies offer compensation for time and travel, but this varies. You should ask the study team directly about any payments if you are interested.