ClinicalTrials.Veeva

Menu

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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Prostatic Neoplasms

Treatments

Drug: Fludrocortisone acetate
Drug: MK-5684
Drug: Prednisone
Drug: Diltiazem hydrocholoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT06554639
MK-5684-011 (Other Identifier)
5684-011

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
  • Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
  • Able to swallow multiple tablets

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • History or presence of any of the following:

    • Adrenal insufficiency
    • Hepatic or renal impairment
    • Clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events
    • Second- or third-degree Atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker)
    • Clinically significant sick sinus syndrome
    • Presence of any systemic fungal infection
    • Chronic infection
    • Glaucoma
    • Hypothyroidism
    • Stomach ulcer
    • Ocular herpes simplex
  • Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)

  • History of cancer (malignancy)

  • Unable to refrain from or anticipants the use of: Unable to refrain from or anticipates the use of: Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

12 participants in 2 patient groups

MK-5684 Period 1
Experimental group
Description:
On Day 1 a single dose of MK-5684 will be administered under fasting conditions and a single dose of HRT (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after MK-5684 dosing.
Treatment:
Drug: Prednisone
Drug: MK-5684
Drug: Fludrocortisone acetate
MK-5684 Period 2
Experimental group
Description:
There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and/or diltiazem dosing.
Treatment:
Drug: Diltiazem hydrocholoride
Drug: Prednisone
Drug: MK-5684
Drug: Fludrocortisone acetate

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems