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

NCT06554639 | Completed Phase 1 FDA Drug

• 2 other identifiers: 5684-011MK-5684-011
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma

  AUC0-inf of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 120 hours post-dose

• Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma

  AUC0-last of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 120 hours post-dose

• Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma

  AUC0-24 of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 24 hours post-dose

• Maximum concentration (Cmax) of MK-5684 in plasma

  Cmax of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 120 hours post-dose

• Time to Maximum concentration (Tmax) of MK-5684 in plasma

  Tmax of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 120 hours post-dose

• Apparent terminal half-life (t1/2) of MK-5684 in plasma

  t1/2 of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 120 hours post-dose

• Apparent Clearance (CL/F) of MK-5684 in plasma

  CL/F of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 120 hours post-dose

• Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma

  Vz/F of MK-5684 in plasma will be determined.

  Predose, and at designated timepoints up to 120 hours post-dose

Secondary Outcomes (2)

• Number of participants who experience one or more adverse events (AEs)

  Up to approximately 39 days

• Number of participants who discontinue study intervention due to an AE

  Up to approximately 39 days

Study Arms (2)

MK-5684 Period 1

EXPERIMENTAL

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.

Drug: MK-5684; Drug: Prednisone; Drug: Fludrocortisone acetate

MK-5684 Period 2

EXPERIMENTAL

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.

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

Interventions

MK-5684 DRUG

Administered via oral tablet per dosing regimen.

MK-5684 Period 1; MK-5684 Period 2

Prednisone DRUG

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

MK-5684 Period 1; MK-5684 Period 2

Fludrocortisone acetate DRUG

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

MK-5684 Period 1; MK-5684 Period 2

Diltiazem hydrocholoride DRUG

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

MK-5684 Period 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Prednisone; fludrocortisone acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: July 11, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 29, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)