Skip to main content
OpenTrials
Completed

NCT Number: NCT06818968

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea CRU, Madison ( Site 0001)

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-6916

Drug

Oral administration

Diltiazem

Drug

Oral administration

Other names: MK-M793

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916

    Time frame: Predose and at designated time points (up to 8 weeks)

    Blood samples will be collected to determine the AUC0-inf of MK-6916.

  2. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916

    Time frame: Predose and at designated time points (up to 24 hours)

    Blood samples will be collected to determine the AUC0-24 of MK-6916.

  3. Plasma Concentration at 24 Hours (C24) of MK-6916

    Time frame: Predose and at designated time points (up to 24 hours)

    Blood samples will be collected to determine the C24 of MK-6916.

  4. Plasma Concentration at 12 Hours (C12) of MK-6916

    Time frame: Predose and at designated time points (up to 12 hours)

    Blood samples will be collected to determine the C12 of MK-6916.

  5. Maximum Plasma Concentration (Cmax) of MK-6916

    Time frame: Predose and at designated time points (up to 8 weeks)

    Blood samples will be collected to determine the Cmax of MK-6916.

  6. Time to Maximum Plasma Concentration (Tmax) of MK-6916

    Time frame: Predose and at designated time points (up to 8 weeks)

    Blood samples will be collected to determine the Tmax of MK-6916.

  7. Apparent Clearance (CL/F) of MK-6916

    Time frame: Predose and at designated time points (up to 8 weeks)

    Blood samples will be collected to determine the CL/F of MK-6916.

  8. Apparent Volume of Distribution (Vz/F) of MK-6916

    Time frame: Predose and at designated time points (up to 8 weeks)

    Blood samples will be collected to determine the Vz/F of MK-6916.

  9. Apparent Terminal Half-life (t1/2) of MK-6916

    Time frame: Predose and at designated time points (up to 8 weeks)

    Blood samples will be collected to determine the t1/2 of MK-6916.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 8 weeks

    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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.