CompletedPhase 1

A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017)

United States14 participantsStarted 2026-05-11

Plain-language summary

Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer. The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called itraconazole.

Who can participate

Age range

19 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a body mass index ≥18.0 and ≤32.0 kg/m\^2 * Is medically healthy with no clinically significant medical history Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history or presence of any of the following: adrenal insufficiency; hepatic or renal impairment; clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events; second- or third-degree atrioventricular heart block; clinically significant sick sinus syndrome; any systemic fungal infection; chronic infection; glaucoma; hypothyroidism; stomach ulcer; ocular herpes simplex; ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome) * Has a history of cancer (malignancy)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Maximum concentration (Cmax) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Time to Maximum concentration (Tmax) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Apparent terminal half-life (t1/2) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Apparent Clearance (CL/F) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Trial details

NCT IDNCT07548606

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

19 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Maximum concentration (Cmax) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Time to Maximum concentration (Tmax) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Apparent terminal half-life (t1/2) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose

Apparent Clearance (CL/F) of opevesostat

Timeframe: Predose, and at designated timepoints up to 144 hours post-dose