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

NCT06692647 | Completed Phase 1 FDA Drug

• 2 other identifiers: 4318-003MK-4318-003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Pain

Outcome Measures

Primary Outcomes (9)

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

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

  At designated timepoints (up to approximately 4 days postdose)

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

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

  At designated timepoints (up to approximately 1 day postdose)

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

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

  At designated timepoints (up to approximately 12 hours postdose)

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

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

  At designated timepoints (up to approximately 1 day postdose)

• Maximum Plasma Concentration (Cmax) of MK-4318

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

  At designated timepoints (up to approximately 4 days postdose)

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

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

  At designated timepoints (up to approximately 4 days postdose)

• Apparent Clearance (CL/F) of MK-4318

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

  At designated timepoints (up to approximately 4 days postdose)

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

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

  At designated timepoints (up to approximately 4 days postdose)

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

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

  At designated timepoints (up to approximately 4 days postdose)

Secondary Outcomes (2)

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

  Up to approximately 60 days

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

  Up to approximately 9 days

Study Arms (1)

MK-4318 Plus Diltiazem

EXPERIMENTAL

Participants will move sequentially through 2 Periods. In Period 1, participants receive MK-4318 orally. In Period 2, participants receive MK-4318 orally plus diltiazem orally.

Drug: MK-4318; Drug: Diltiazem

Interventions

MK-4318 DRUG

Oral administration

MK-4318 Plus Diltiazem

Diltiazem DRUG

Oral administration

Also known as: Cardizem®, Cartia XT®, Matzim LA®

MK-4318 Plus Diltiazem

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Labcorb CRU, Madison (Site 0001)

Madison, Wisconsin, 53704, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Pain

Interventions

Diltiazem

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: February 9, 2024
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)