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ACTIVE NOT RECRUITING
NCT07548606
PHASE1

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

19 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2026-05-11

Completion Date

2026-06-14

Last Updated

2026-06-12

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Opevesostat

Administered via oral film-coated tablet

DRUG

Prednisone

Administered via oral tablet

DRUG

Fludrocortisone acetate

Administered via oral tablet

DRUG

Itraconazole

Administered via oral capsule

Locations (1)

Celerion, Inc. ( Site 0001)

Lincoln, Nebraska, United States