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Completed

NCT Number: NCT07548606

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

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc. ( Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Opevesostat

Drug

Administered via oral film-coated tablet

Other names: MK-5684, ODM-208

Prednisone

Drug

Administered via oral tablet

fludrocortisone acetate

Drug

Administered via oral tablet

Itraconazole

Drug

Administered via oral capsule

Primary outcomes

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

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

    Blood samples will be collected to determine the AUC0-inf of opevesostat.

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

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

    Blood samples will be collected to determine the AUC0-last of opevesostat.

  3. Maximum concentration (Cmax) of opevesostat

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

    Blood samples will be collected to determine the Cmax of opevesostat.

  4. Time to Maximum concentration (Tmax) of opevesostat

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

    Blood samples will be collected to determine the Tmax of opevesostat.

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

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

    Blood samples will be collected to determine the t1/2 of opevesostat.

  6. Apparent Clearance (CL/F) of opevesostat

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

    Blood samples will be collected to determine the CL/F of opevesostat.

  7. Apparent volume of distribution during terminal phase (Vz/F) of opevesostat

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

    Blood samples will be collected to determine the Vz/F of opevesostat.

Secondary outcomes

  1. Number of participants who experience one or more adverse events (AEs)

    Time frame: Up to approximately 28 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  2. Number of participants who discontinue study intervention due to an AE

    Time frame: Up to approximately 28 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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