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.

Who Can Join the Study?

Who Cannot Join the Study?

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

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
07.08.2023

Trial locations

Investigated Diseases:

Trial ID:
2023-505521-14-00
Protocol code:
MK-5684-007
Trial Phase:
Human Pharmacology (Phase I) – Other

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