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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
oral
oral
oral
oral
Per local product label
Pharmacokinetics (PK) of Fezolinetant in plasma: Maximum Concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to Day 3
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.
Time frame: Up to Day 3
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.
Time frame: Up to Day 12
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 12
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 12
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Time frame: Up to Day 12
PK of metabolite ES259564 in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to Day 3
PK of metabolite ES259564 in plasma: AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Time frame: Up to Day 3
Metabolite ES259564 to parent ratio for AUCinf
Metabolite ES259564 AUCinf and Fezolinetant AUCinf will be recorded from the PK plasma samples collected.
Time frame: Up to Day 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.