Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-6916 + Diltiazem | Experimental | Participants will receive MK-6916 and diltiazem orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6916 | Drug | Oral administration |
| |
| Diltiazem |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916 | Blood samples will be collected to determine the AUC0-inf of MK-6916. | Predose and at designated time points (up to 8 weeks) |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916 | Blood samples will be collected to determine the AUC0-24 of MK-6916. | Predose and at designated time points (up to 24 hours) |
| Plasma Concentration at 24 Hours (C24) of MK-6916 | Blood samples will be collected to determine the C24 of MK-6916. | Predose and at designated time points (up to 24 hours) |
| Plasma Concentration at 12 Hours (C12) of MK-6916 | Blood samples will be collected to determine the C12 of MK-6916. | Predose and at designated time points (up to 12 hours) |
| Maximum Plasma Concentration (Cmax) of MK-6916 | Blood samples will be collected to determine the Cmax of MK-6916. | Predose and at designated time points (up to 8 weeks) |
| Time to Maximum Plasma Concentration (Tmax) of MK-6916 | Blood samples will be collected to determine the Tmax of MK-6916. | Predose and at designated time points (up to 8 weeks) |
| Apparent Clearance (CL/F) of MK-6916 | Blood samples will be collected to determine the CL/F of MK-6916. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 8 weeks |
Not provided
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea CRU, Madison ( Site 0001) | Madison | Wisconsin | 53704 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral administration |
|
|
| Predose and at designated time points (up to 8 weeks) |
| Apparent Volume of Distribution (Vz/F) of MK-6916 | Blood samples will be collected to determine the Vz/F of MK-6916. | Predose and at designated time points (up to 8 weeks) |
| Apparent Terminal Half-life (t1/2) of MK-6916 | Blood samples will be collected to determine the t1/2 of MK-6916. | Predose and at designated time points (up to 8 weeks) |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 8 weeks |