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

NCT06818968 | Completed Phase 1 FDA Drug

• 1 other identifier: 6916-005
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 8 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 8 weeks

Study Arms (1)

MK-6916 + Diltiazem

EXPERIMENTAL

Participants will receive MK-6916 and diltiazem orally.

Drug: MK-6916; Drug: Diltiazem

Interventions

MK-6916 DRUG

Oral administration

MK-6916 + Diltiazem

Diltiazem DRUG

Oral administration

Also known as: MK-M793

MK-6916 + Diltiazem

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Fortrea CRU, Madison ( Site 0001)

Madison, Wisconsin, 53704, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Diltiazem

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: February 27, 2025
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)