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Предстои набиране Фаза 1 NCT07548606

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Healthy

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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.
Кой може да участва
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)
Интервенции
Opevesostat
DRUG
Prednisone
DRUG
Fludrocortisone acetate
DRUG
Itraconazole
DRUG
Места на провеждане

Информация за локации не е налична.

Технически детайли
Статус
Предстои набиране
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
19 Years
Максимална възраст
55 Years
Здрави доброволци
Не
Начална дата
04.05.2026
Крайна дата
14.06.2026
Регистрационен номер
NCT07548606
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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