Healthy
Conditions
Brief summary
The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.
Interventions
DRUGMK-6552
Oral Gelatin Coated Capsule
DRUGDiltiazem
Oral Extended-Release Capsule
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
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 before randomization * Body Mass Index (BMI) between 18 and 32 kg/m\^2, inclusive
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of MK-6552 | Pre-dose and at designated time points up to 24 hours post dose | Blood samples will be collected to determine the Cmax of MK-6552 in plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Due to an AE | Up to approximately 20 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. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 | Pre-dose and at designated time points up to 96 hours post dose | Blood samples will be collected to determine the AUC0-inf of MK-6552 in plasma. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552 | Pre-dose and at designated time points up to 24 hours post dose | Blood samples will be collected to determine the AUC0-24 of MK-6552 in plasma. |
| Time to Maximum Plasma Concentration (Tmax) of MK-6552 | Pre-dose and at designated time points up to 96 hours post dose | Blood samples will be collected to determine the Tmax of MK-6552 in plasma. |
| Number of Participants Who Experience and Adverse Event (AEs) | Up to approximately 20 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. |
| Concentration of MK-6552 at 8 Hours Postdose (C8h) | Pre-dose and at designated time points up to 8 hours post dose | Blood samples will be collected to determine the C8h of MK-6552 in plasma. |
| Apparent Clearance (CL/F) of MK-6552 | Pre-dose and at designated time points up to 96 hours post dose | Blood samples will be collected to determine the CL/F of MK-6552 in plasma. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552 | Pre-dose and at designated time points up to 96 hours post dose | Blood samples will be collected to determine the Vz/F of MK-6552 in plasma. |
| Apparent Terminal Half-Life (t1/2) of MK-6552 | Pre-dose and at designated time points up to 96 hours post dose | Blood samples will be collected to determine the t1/2 of MK-6552 in plasma. |
| Concentration of MK-6552 at 6 Hours Postdose (C6h) | Pre-dose and at designated time points up to 6 hours post dose | Blood samples will be collected to determine the C6h of MK-6552 in plasma. |
Countries
United States
Outcome results
None listed