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A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)

NCT06633419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-05-25

No results posted yet for this study

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 carbamazepine.

Conditions

  • Healthy

Interventions

DRUG

Opevesostat

Administered via oral tablet per dosing regimen.

DRUG

Prednisone

Administered at a dose of 5 mg or 10 mg dependent on HRT dosing regimen via oral tablets.

DRUG

Fludrocortisone acetate

Administered at a dose of 0.05 mg or 0.1 mg dependent on HRT dosing regimen via oral tablets.

DRUG

Carbamazepine

Administered at a dose of 100 mg, 200 mg, or 300 mg BID dependent on dosing regimen via oral capsule (extended-release).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2025-02-12
Completion
2025-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06633419 on ClinicalTrials.gov