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

Phase 1Active Not RecruitingNCT07548606

Merck Sharp & Dohme LLC14 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

OpevesostatDRUG

Administered via oral film-coated tablet

PrednisoneDRUG

Administered via oral tablet

Fludrocortisone acetateDRUG

Administered via oral tablet

Itraconazole

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Celerion, Inc. ( Site 0001)

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

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.