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Not yet recruiting Phase 1 NCT07548606

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: Merck Sharp & Dohme LLC

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Overview
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
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)
Interventions
Opevesostat
DRUG
Prednisone
DRUG
Fludrocortisone acetate
DRUG
Itraconazole
DRUG
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
19 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
04.05.2026
Completion date
14.06.2026
Registry ID
NCT07548606
Source
clinicaltrials.gov
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