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

NCT07548606 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 5684-017MK-5684-017
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

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

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

  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

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

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

• Maximum concentration (Cmax) of opevesostat

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

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

• Time to Maximum concentration (Tmax) of opevesostat

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

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

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

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

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

• Apparent Clearance (CL/F) of opevesostat

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

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

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

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

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

Secondary Outcomes (2)

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

  Up to approximately 28 days

• Number of participants who discontinue study intervention due to an AE

  Up to approximately 28 days

Study Arms (2)

Opevesostat Period 1

EXPERIMENTAL

On Day 1, a single dose of opevesostat will be administered under fed conditions. A single dose of steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.

Drug: Opevesostat; Drug: Prednisone; Drug: Fludrocortisone acetate

Opevesostat Period 2

EXPERIMENTAL

There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, itraconazole will be administered once daily (QD) for 9 consecutive days with a single dose of opevesostat coadministered on Day 4 under fed conditions. Steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 4 through 6, approximately 4.5 hours after opevesostat and/or itraconazole dosing.

Drug: Opevesostat; Drug: Prednisone; Drug: Fludrocortisone acetate; Drug: Itraconazole

Interventions

Opevesostat DRUG

Administered via oral film-coated tablet

Also known as: MK-5684, ODM-208

Opevesostat Period 1; Opevesostat Period 2

Prednisone DRUG

Administered via oral tablet

Opevesostat Period 1; Opevesostat Period 2

Fludrocortisone acetate DRUG

Administered via oral tablet

Opevesostat Period 1; Opevesostat Period 2

Itraconazole DRUG

Administered via oral capsule

Opevesostat Period 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has a body mass index ≥18.0 and ≤32.0 kg/m\^2
• Is medically healthy with no clinically significant medical history

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion, Inc. ( Site 0001)

Lincoln, Nebraska, 68502, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Prednisone; fludrocortisone acetate; Itraconazole

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@merck.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)