Interaction between itraconazole and opevesostat in healthy adult men

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

This test checks how the experimental prostate cancer drug opevesostat is processed in healthy adult men when taken with and without the antifungal itraconazole.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 19 Years to 55 Years
• Sex: Male
• Sponsor: Merck Sharp & Dohme LLC (Industry-sponsored)
• Locations: 1 site (Lincoln, Nebraska)
• Trial ID: NCT07548606 on ClinicalTrials.gov

What this trial studies

This Phase 1 pharmacokinetic study enrolls healthy adult male volunteers to measure how opevesostat is absorbed, distributed, metabolized, and eliminated when given alone and when coadministered with itraconazole. Participants will receive scheduled doses of opevesostat and, in a separate period, itraconazole, with supportive medications such as prednisone and fludrocortisone acetate included per protocol. Serial blood sampling will quantify drug concentrations and compare key PK parameters like peak concentration, area under the curve, and clearance. Results will identify whether itraconazole meaningfully changes opevesostat exposure and inform safe dosing when both drugs are used together.

Who should consider this trial

Good fit: Healthy adult men with a BMI of 18–32 kg/m2 who are medically healthy with no significant medical history or history of cancer are the intended participants.

Not a fit: People with active medical conditions, a history of cancer, or excluded cardiac, endocrine, infectious, hepatic, or renal impairments would not be eligible and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, results could help doctors give safe and effective doses of opevesostat when patients also need itraconazole or similar drugs.

How similar studies have performed: Drug–drug interaction PK studies using itraconazole as a CYP3A inhibitor are common and have successfully guided dosing for other oncology medications.

Eligibility criteria

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)

Where this trial is running

Lincoln, Nebraska

• Celerion, Inc. ( Site 0001) — Lincoln, Nebraska, United States (Recruiting)

Study contacts

• Study coordinator: Toll Free Number

Conditions Healthy