Healthy, Pain
Conditions
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.
Interventions
DRUGMK-4318
Oral administration
DRUGDiltiazem
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Terminal Half-life (t1/2) of MK-4318 | 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. |
| Apparent Clearance (CL/F) of MK-4318 | 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. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4318 | 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. |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4318 | 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. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-4318 | 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. |
| Plasma Concentration of MK-4318 at 12 Hours Postdose (C12hrs) | 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. |
| Plasma Concentration of MK-4318 at 24 Hours Postdose (C24hrs) | 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. |
| Maximum Plasma Concentration (Cmax) of MK-4318 | 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. |
| Time to Maximum Plasma Concentration (Tmax) of MK-4318 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Intervention Due to an AE | 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. |
| Number of Participants Who Experience an Adverse Event (AE) | 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. |
Countries
United States
Outcome results
None listed