A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017)
NCT07548606 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2026-04-30
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.
Conditions
- Healthy
Interventions
- DRUG
-
Opevesostat
Administered via oral film-coated tablet
- DRUG
-
Administered via oral tablet
- DRUG
-
Fludrocortisone acetate
Administered via oral tablet
- DRUG
-
Itraconazole
Administered via oral capsule
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-05-04
- Primary Completion
- 2026-06-01
- Completion
- 2026-06-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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