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A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)

NCT06554639 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-15

No results posted yet for this study

Summary

Researchers have designed a study medicine called MK-5684 as a new way to treat prostate cancer.

The purpose of this study is to learn what happens to MK-5684 in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to MK-5684 in the body when it is given with and without another medicine called diltiazem.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

MK-5684

Administered via oral tablet per dosing regimen.

DRUG

Prednisone

Administered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets.

DRUG

Fludrocortisone acetate

Administered at a dose of 0.05 mg per HRT dosing regimen via oral tablets.

DRUG

Diltiazem hydrocholoride

Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2024-08-05
Completion
2024-08-29
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 NCT06554639 on ClinicalTrials.gov