A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)
- Registration Number
- NCT06692647
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-4318 Plus Diltiazem MK-4318 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. MK-4318 Plus Diltiazem Diltiazem 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Labcorb CRU, Madison (Site 0001)
🇺🇸Madison, Wisconsin, United States