Effect of a high‑fat meal on MK‑5684, fludrocortisone and prednisone pharmacokinetics and hormone levels in healthy men relevant to refractory metastatic prostate cancer

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What is this study about?

The study focuses on refractory metastatic prostate cancer, a form of prostate cancer that continues to grow and spread despite standard treatments. The investigational medication being examined is identified by the code name MK-5684, which is taken as a single oral tablet.

The purpose of the trial is to determine how a high-fat meal influences the pharmacokinetics of the drug—meaning how quickly and how much of the medication enters the bloodstream—and to observe any changes in steroid hormone levels such as testosterone over time. Healthy male volunteers receive the tablet twice: once after an overnight fast and once after eating a fatty meal, with a short break between the two dosing periods.

During each visit, blood samples are collected at several time points to measure the amount of drug and hormone levels in the plasma, the liquid part of blood. Participants are monitored for any side effects throughout the short study period, and all procedures are designed to be safe and well‑tolerated.

1 initial visit and background medication

you attend the first study visit after you have been enrolled. during this visit you receive instructions on how to take the study drugs and you continue your regular background medications.

the background medications are fludrocortisone 0.05 mg tablet taken once daily and prednisone 5 mg tablet taken once daily. fludrocortisone is a synthetic hormone that helps maintain salt and water balance, and prednisone is a steroid that reduces inflammation. you keep taking these pills as directed for the entire duration of the trial.

2 first dosing period – fasted state

after an overnight fast of at least eight hours, you come to the clinic and take a single 5 mg film‑coated tablet of odm-208 tosilate by mouth.

following the dose, blood samples are collected at several time points over the next several hours. these samples are used to measure the amount of odm-208 tosilate in your blood and to monitor changes in hormone levels such as testosterone and other steroids.

you remain at the clinic for the duration of the blood‑draw schedule and are observed for any immediate reactions.

3 washout period

after the first dosing period you do not take any more study drug for a washout period that allows the medication to be fully cleared from your body. the exact length of this period is determined by the study protocol.

during the washout you continue to take your background medications (fludrocortisone and prednisone) as usual.

4 second dosing period – fed state

you eat a standardized high‑fat meal provided by the study staff.

within a short time after finishing the meal, you take another single 5 mg tablet of odm-208 tosilate by mouth.

blood samples are drawn at the same time points as in the fasted period to compare how food affects the drug’s absorption and its impact on hormone levels.

you stay at the clinic for the monitoring and sample collection.

5 final visit and study completion

after the last blood draw you attend a final visit where safety checks are performed and any remaining study medication is returned.

the study team reviews the overall findings with you and answers any remaining questions.

Who Can Join the Study?

Must be a male participant.
Must be a healthy volunteer without serious medical problems.
Must be within the adult age range required by the study (typically an adult, such as 18 years or older).
Must have a body mass index (BMI) of at least 18 and no more than 32; BMI is a number that compares a person’s weight to their height.
Must be able to take a single oral (by mouth) dose of the study medication.

Who Cannot Join the Study?

Has had serious hormone (endocrine), digestive (gastrointestinal or GI), heart (cardiovascular), blood (hematological), liver (hepatic), immune system (immunological), kidney (renal), breathing (respiratory), urinary (genitourinary), or brain/spinal cord (neurological) problems.
Regularly uses cannabis or any illegal drugs, or has used drugs of abuse within the past 12 months.
The doctor believes participation may not be safe for you or has another reason to consider you unsuitable.
You or an immediate family member work as staff at the study site or for the sponsor of the study.
Has ever had cancer.
Has severe allergies, especially a life‑threatening (anaphylactic) reaction, or cannot tolerate certain medicines or foods.
Tests positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV (human immunodeficiency virus).
Cannot stop taking any medication, including prescription, over‑the‑counter, or herbal products, starting at least two weeks before the first dose and continuing through the study.
Has received or plans to receive any vaccination within two weeks before the study, during the study, or after the study.
Has any reason not to take prednisone or fludrocortisone (both are steroid medicines).
Currently smokes or has used nicotine products (such as cigarettes, vaping, or chewing tobacco) within the past three months.
Drinks more than three servings of alcohol per day (four or more may be allowed only if the doctor decides).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	07.08.2023

Trial locations

Investigated Drugs:

Astonin H is a tablet that contains fludrocortisone, a type of steroid hormone. It helps the body keep the right balance of salt and water, which can affect blood pressure and the amount of fluid in the body. In this study, it was given as a background medication to see how it might influence other measurements.

Prednison acis is a tablet that contains prednisone, another steroid hormone. Prednisone is used to reduce inflammation and affect the immune system. In the trial, it was also taken as a background medication to provide a consistent condition for the participants.

ODM-208 TOSILATE is an experimental oral tablet being tested in this study. It is the main drug under investigation, and the researchers are looking at how food (a high‑fat meal) changes the way the body absorbs and processes this medication, as well as how it influences hormone levels over time.

Investigated Diseases:

Prostate cancer metastatic

Metastatic castration‑resistant prostate cancer (mCRPC) – This disease is prostate cancer that has spread from the prostate gland to other parts of the body, such as bone or lymph nodes, and continues to grow despite hormonal therapy that lowers testosterone. The cancer cells become able to survive and multiply without the need for normal hormone signals, leading to ongoing tumor growth. As the disease advances, cancer lesions can increase in size and number, often affecting the skeleton and causing new areas of spread. The condition may progress silently for a time, but over months to years the tumor burden can increase, resulting in worsening symptoms.

Trial ID:

2023-505521-14-00

Protocol code:

MK-5684-007

Trial Phase:

Human Pharmacology (Phase I) – Other

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Effect of a high‑fat meal on MK‑5684, fludrocortisone and prednisone pharmacokinetics and hormone levels in healthy men relevant to refractory metastatic prostate cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?