Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of testosterone in the body. One of the side effects of hormone therapy is hot flashes. There is an unmet medical need to treat hot flashes in men undergoing hormone therapy for prostate cancer. This study will help researchers understand if hormone therapy (enzalutamide, apalutamide or bicalutamide) affects the way fezolinetant is processed by the body in men with prostate cancer.
The main aim of this study is checking levels of fezolinetant in the blood over time to learn how long it takes to get into the blood, spread through the body and be cleared from the body.
Men with prostate cancer or healthy men can take part. The men with prostate cancer will have already been taking standard hormone therapy (enzalutamide, apalutamide or bicalutamide) for a few months. Men cannot take part if they have recently had major surgery, have had an infection, have a heart condition, or have gut problems. Men with prostate cancer cannot take part if they have other cancers, have recently had certain treatments for prostate cancer, have certain ongoing medical conditions or any chronic disease. This includes any liver problems.
There will be 4 groups in this study:
Group 1 - men with prostate cancer who are taking enzalutamide will be given fezolinetant.
Group 2 - men with prostate cancer who are taking apalutamide will be given fezolinetant.
Group 3 - men with prostate cancer who are taking bicalutamide will be given fezolinetant.
Group 4 - healthy men will only be given fezolinetant.
The men taking part in the study will stay in the clinic for a few days and nights. The men will have nothing to eat or drink for several hours before taking 1 tablet of fezolinetant. Blood samples will be taken and health checks done. During their stay, the men with prostate cancer will continue to be given the standard dose of their hormone therapy. All the men in the study will continue to have regular health checks and will be asked if they have any medical problems. After the men leave the clinic, they will return to the clinic about a week later for a final health check.
Participant is born male, inclusive of all gender ideologies.
Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 30 days after final fezolinetant administration.
Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 30 days after final study intervention administration.
Male participant must not donate sperm during the treatment period and for 30 days after final study intervention administration.
Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 2 days) after the last dose of study drug administration or end-of-study visit (ESV), whichever is longer.
Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.
Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual (American Psychiatric Association), Fifth Edition (DSM-5) criteria within 2 years before screening.
Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
Parallel
fezolinetant
Drugoral
enzalutamide
Drugoral
apalutamide
Drugoral
bicalutamide
Drugoral
GnRH agonist/antagonist
DrugPer local product label
Pharmacokinetics (PK) of Fezolinetant in plasma: Maximum Concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
PK of Fezolinetant in plasma: Area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK plasma samples collected.
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
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