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

NCT ID: NCT06554639

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2024-08-29

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-5684 Period 1

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.

Group Type: EXPERIMENTAL

MK-5684

Intervention Type: DRUG

Administered via oral tablet per dosing regimen.

Prednisone

Intervention Type: DRUG

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

Fludrocortisone acetate

Intervention Type: DRUG

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

MK-5684 Period 2

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.

Group Type: EXPERIMENTAL

MK-5684

Intervention Type: DRUG

Administered via oral tablet per dosing regimen.

Prednisone

Intervention Type: DRUG

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

Fludrocortisone acetate

Intervention Type: DRUG

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

Diltiazem hydrocholoride

Intervention Type: DRUG

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

Interventions

MK-5684

Administered via oral tablet per dosing regimen.

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

Fludrocortisone acetate

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

Intervention Type: DRUG

Diltiazem hydrocholoride

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Celerion ( Site 0001)

Tempe, Arizona, United States

Countries

United States

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-5684-011

Identifier Type: OTHER

Identifier Source: secondary_id

5684-011

Identifier Type: -

Identifier Source: org_study_id