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
Merck Sharp & Dohme LLC
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.
Eligibility
- Age range
- 19–55 years
- Sex
- Male
- Healthy volunteers
- Yes
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…
Interventions
- DrugOpevesostat
Administered via oral film-coated tablet
- DrugPrednisone
Administered via oral tablet
- DrugFludrocortisone acetate
Administered via oral tablet
- DrugItraconazole
Administered via oral capsule
Location
- Celerion, Inc. ( Site 0001)Lincoln, Nebraska