NCT06554639

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

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2024-07-11
• Primary completion: 2024-08-05
• Completion: 2024-08-29
• First posted: 2024-08-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study