A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)

A 2-period, Fixed-sequence, Open-label Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-dose Pharmacokinetics of MK-6916 in Healthy Participants

The goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body over time. Researchers will compare what happens to MK-6916 in the body when it is given with or without another medicine called diltiazem.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Diltiazem; Drug: MK-6916

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea CRU, Madison ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

• Has a body-mass index (BMI) 18 to 32 kg/m^2

Exclusion Criteria:

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

• Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
• Has a history of cancer (malignancy)
• Has a history of cardiac arrhythmia or recurrent unexplained syncopal events
• 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
• Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-6916 + Diltiazem; Participants will receive MK-6916 and diltiazem orally.	Drug: Diltiazem; Oral administration; Other Names: MK-M793; Drug: MK-6916; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916	Blood samples will be collected to determine the AUC0-inf of MK-6916.	Predose and at designated time points (up to 8 weeks)
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916	Blood samples will be collected to determine the AUC0-24 of MK-6916.	Predose and at designated time points (up to 24 hours)
Plasma Concentration at 24 Hours (C24) of MK-6916	Blood samples will be collected to determine the C24 of MK-6916.	Predose and at designated time points (up to 24 hours)
Plasma Concentration at 12 Hours (C12) of MK-6916	Blood samples will be collected to determine the C12 of MK-6916.	Predose and at designated time points (up to 12 hours)
Maximum Plasma Concentration (Cmax) of MK-6916	Blood samples will be collected to determine the Cmax of MK-6916.	Predose and at designated time points (up to 8 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-6916	Blood samples will be collected to determine the Tmax of MK-6916.	Predose and at designated time points (up to 8 weeks)
Apparent Clearance (CL/F) of MK-6916	Blood samples will be collected to determine the CL/F of MK-6916.	Predose and at designated time points (up to 8 weeks)
Apparent Volume of Distribution (Vz/F) of MK-6916	Blood samples will be collected to determine the Vz/F of MK-6916.	Predose and at designated time points (up to 8 weeks)
Apparent Terminal Half-life (t1/2) of MK-6916	Blood samples will be collected to determine the t1/2 of MK-6916.	Predose and at designated time points (up to 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event (AE)	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. The number of participants who experience an AE will be reported.	Up to approximately 8 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE	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. The number of participants who discontinue study treatment due to an AE will be reported.	Up to approximately 8 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Diltiazem
• Other Study ID Numbers: 6916-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/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