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Completed

NCT Number: NCT06692647

A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)

The goal of this study is to learn what happens to MK-4318 in a person's body over time. Researchers will compare what happens to levels of MK-4318 in people's blood when it is taken with and without diltiazem. Researchers also want to learn about the safety of MK-4318 taken with and without diltiazem and if people tolerate them.

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Key information

Conditions

Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorb 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 main inclusion criteria include but are not limited to the following:

  • Is in good health based on medical history and physical examination
  • Has a body mass index >18 and ≤32 kg/m^2, inclusive

Exclusion criteria

The main 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 (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cardiac arrythmia or recurrent unexplained syncopal events

Treatment and study plan

MK-4318

Drug

Oral administration

Diltiazem

Drug

Oral administration

Other names: Cardizem®, Cartia XT®, Matzim LA®

Primary outcomes

  1. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4318

    Time frame: At designated timepoints (up to approximately 4 days postdose)

    Blood samples will be collected to determine the AUC0-inf of MK-4318 in the presence of diltiazem.

  2. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-4318

    Time frame: At designated timepoints (up to approximately 1 day postdose)

    Blood samples will be collected to determine the AUC0-24hrs of MK-4318 in the presence of diltiazem.

  3. Plasma Concentration of MK-4318 at 12 Hours Postdose (C12hrs)

    Time frame: At designated timepoints (up to approximately 12 hours postdose)

    Blood samples will be collected to determine the C12hrs of MK-4318 in the presence of diltiazem.

  4. Plasma Concentration of MK-4318 at 24 Hours Postdose (C24hrs)

    Time frame: At designated timepoints (up to approximately 1 day postdose)

    Blood samples will be collected to determine the C24hrs of MK-4318 in the presence of diltiazem.

  5. Maximum Plasma Concentration (Cmax) of MK-4318

    Time frame: At designated timepoints (up to approximately 4 days postdose)

    Blood samples will be collected to determine the Cmax of MK-4318 in the presence of diltiazem.

  6. Time to Maximum Plasma Concentration (Tmax) of MK-4318

    Time frame: At designated timepoints (up to approximately 4 days postdose)

    Blood samples will be collected to determine the Tmax of MK-4318 in the presence of diltiazem.

  7. Apparent Clearance (CL/F) of MK-4318

    Time frame: At designated timepoints (up to approximately 4 days postdose)

    Blood samples will be collected to determine the CL/F of MK-4318 in the presence of diltiazem.

  8. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4318

    Time frame: At designated timepoints (up to approximately 4 days postdose)

    Blood samples will be collected to determine the Vz/F of MK-4318 in the presence of diltiazem.

  9. Apparent Terminal Half-life (t1/2) of MK-4318

    Time frame: At designated timepoints (up to approximately 4 days postdose)

    Blood samples will be collected to determine the t1/2 of MK-4318 in the presence of diltiazem.

Secondary outcomes

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

    Time frame: Up to approximately 60 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. The number of participants who experience an AE will be reported.

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

    Time frame: Up to approximately 9 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. The number of participants who discontinue study intervention due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Two-period Study to Evaluate the Effects of Multiple Oral Doses of Diltiazem on the Single-dose Pharmacokinetics of MK-4318 in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

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.

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