A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)

October 25, 2024 updated by: Merck Sharp & Dohme LLC

A Study to Evaluate the Effects of Coadministration of Diltiazem on the Plasma Pharmacokinetics of a Single Dose of MK-6552 in Healthy Participants

The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • ICON (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:

  • Is in good health before randomization
  • Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion Criteria:

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

  • History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • History of cancer (malignancy)

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-6552 + Diltiazem
Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552.
Drug: MK-6552
Oral Gelatin Coated Capsule
Drug: Diltiazem
Oral Extended-Release Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of MK-6552
Time Frame: Pre-dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the Cmax of MK-6552 in plasma.
Pre-dose and at designated time points up to 24 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience and Adverse Event (AEs)
Time Frame: Up to approximately 20 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 20 days
Number of Participants Who Discontinue Study Due to an AE
Time Frame: Up to approximately 20 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 20 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of MK-6552 in plasma.
Pre-dose and at designated time points up to 96 hours post dose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552
Time Frame: Pre-dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the AUC0-24 of MK-6552 in plasma.
Pre-dose and at designated time points up to 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of MK-6552
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Tmax of MK-6552 in plasma.
Pre-dose and at designated time points up to 96 hours post dose
Concentration of MK-6552 at 6 Hours Postdose (C6h)
Time Frame: Pre-dose and at designated time points up to 6 hours post dose
Blood samples will be collected to determine the C6h of MK-6552 in plasma.
Pre-dose and at designated time points up to 6 hours post dose
Concentration of MK-6552 at 8 Hours Postdose (C8h)
Time Frame: Pre-dose and at designated time points up to 8 hours post dose
Blood samples will be collected to determine the C8h of MK-6552 in plasma.
Pre-dose and at designated time points up to 8 hours post dose
Apparent Clearance (CL/F) of MK-6552
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the CL/F of MK-6552 in plasma.
Pre-dose and at designated time points up to 96 hours post dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Vz/F of MK-6552 in plasma.
Pre-dose and at designated time points up to 96 hours post dose
Apparent Terminal Half-Life (t1/2) of MK-6552
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the t1/2 of MK-6552 in plasma.
Pre-dose and at designated time points up to 96 hours post dose

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)

June 13, 2024

Primary Completion (Actual)

September 27, 2024

Study Completion (Actual)

September 27, 2024

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6552-007
  • MK-6552-007 (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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