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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4318-003 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4318 Plus Diltiazem | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4318 | Drug | Oral administration |
| |
| Diltiazem |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4318 | Blood samples will be collected to determine the AUC0-inf of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 4 days postdose) |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-4318 | Blood samples will be collected to determine the AUC0-24hrs of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 1 day postdose) |
| Plasma Concentration of MK-4318 at 12 Hours Postdose (C12hrs) | Blood samples will be collected to determine the C12hrs of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 12 hours postdose) |
| Plasma Concentration of MK-4318 at 24 Hours Postdose (C24hrs) | Blood samples will be collected to determine the C24hrs of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 1 day postdose) |
| Maximum Plasma Concentration (Cmax) of MK-4318 | Blood samples will be collected to determine the Cmax of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 4 days postdose) |
| Time to Maximum Plasma Concentration (Tmax) of MK-4318 | Blood samples will be collected to determine the Tmax of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 4 days postdose) |
| 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 60 days |
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Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorb CRU, Madison (Site 0001) | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Oral administration |
|
|
| Apparent Clearance (CL/F) of MK-4318 | Blood samples will be collected to determine the CL/F of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 4 days postdose) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4318 | Blood samples will be collected to determine the Vz/F of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 4 days postdose) |
| Apparent Terminal Half-life (t1/2) of MK-4318 | Blood samples will be collected to determine the t1/2 of MK-4318 in the presence of diltiazem. | At designated timepoints (up to approximately 4 days postdose) |
| Number of Participants Who Discontinue Study Intervention 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 intervention due to an AE will be reported. | Up to approximately 9 days |