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

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)

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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