Healthy
Conditions
Brief summary
The goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body over time. Researchers will compare what happens to MK-6916 in the body when it is given with or without another medicine called diltiazem.
Interventions
DRUGMK-6916
Oral administration
DRUGDiltiazem
Oral administration
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 key inclusion criteria include but are not limited to the following: * Has a body-mass index (BMI) 18 to 32 kg/m\^2
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Terminal Half-life (t1/2) of MK-6916 | Predose and at designated time points (up to 8 weeks) | Blood samples will be collected to determine the t1/2 of MK-6916. |
| Apparent Clearance (CL/F) of MK-6916 | Predose and at designated time points (up to 8 weeks) | Blood samples will be collected to determine the CL/F of MK-6916. |
| Apparent Volume of Distribution (Vz/F) of MK-6916 | Predose and at designated time points (up to 8 weeks) | Blood samples will be collected to determine the Vz/F of MK-6916. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916 | Predose and at designated time points (up to 8 weeks) | Blood samples will be collected to determine the AUC0-inf of MK-6916. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916 | Predose and at designated time points (up to 24 hours) | Blood samples will be collected to determine the AUC0-24 of MK-6916. |
| Plasma Concentration at 24 Hours (C24) of MK-6916 | Predose and at designated time points (up to 24 hours) | Blood samples will be collected to determine the C24 of MK-6916. |
| Plasma Concentration at 12 Hours (C12) of MK-6916 | Predose and at designated time points (up to 12 hours) | Blood samples will be collected to determine the C12 of MK-6916. |
| Maximum Plasma Concentration (Cmax) of MK-6916 | Predose and at designated time points (up to 8 weeks) | Blood samples will be collected to determine the Cmax of MK-6916. |
| Time to Maximum Plasma Concentration (Tmax) of MK-6916 | Predose and at designated time points (up to 8 weeks) | Blood samples will be collected to determine the Tmax of MK-6916. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 8 weeks | 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 treatment due to an AE will be reported. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 8 weeks | 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