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

October 10, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma
Time Frame: Predose, and at designated timepoints up to 120 hours post-dose
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
Time Frame: Predose, and at designated timepoints up to 120 hours post-dose
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
Time Frame: Predose, and at designated timepoints up to 24 hours post-dose
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
Time Frame: Predose, and at designated timepoints up to 120 hours post-dose
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
Time Frame: Predose, and at designated timepoints up to 120 hours post-dose
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
Time Frame: Predose, and at designated timepoints up to 120 hours post-dose
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
Time Frame: Predose, and at designated timepoints up to 120 hours post-dose
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
Time Frame: Predose, and at designated timepoints up to 120 hours post-dose
Vz/F of MK-5684 in plasma will be determined.
Predose, and at designated timepoints up to 120 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to approximately 39 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 39 days
Number of participants who discontinue study intervention due to an AE
Time Frame: Up to approximately 39 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 39 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2024

Primary Completion (Actual)

August 5, 2024

Study Completion (Actual)

August 29, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5684-011
  • MK-5684-011 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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