Clinical trial NCT06692647: A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pain
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4318
timeFrame: At designated timepoints (up to approximately 4 days postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-4318
timeFrame: At designated timepoints (up to approximately 1 day postdose)
measure: Plasma Concentration of MK-4318 at 12 Hours Postdose (C12hrs)
timeFrame: At designated timepoints (up to approximately 12 hours postdose)
measure: Plasma Concentration of MK-4318 at 24 Hours Postdose (C24hrs)
timeFrame: At designated timepoints (up to approximately 1 day postdose)
measure: Maximum Plasma Concentration (Cmax) of MK-4318
timeFrame: At designated timepoints (up to approximately 4 days postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of MK-4318
timeFrame: At designated timepoints (up to approximately 4 days postdose)
measure: Apparent Clearance (CL/F) of MK-4318
timeFrame: At designated timepoints (up to approximately 4 days postdose)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4318
timeFrame: At designated timepoints (up to approximately 4 days postdose)
measure: Apparent Terminal Half-life (t1/2) of MK-4318
timeFrame: At designated timepoints (up to approximately 4 days postdose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 60 days
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 9 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorb CRU, Madison (Site 0001)
state: Wisconsin
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: