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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6552-007 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-6552 + Diltiazem | Experimental | Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6552 | Drug | Oral Gelatin Coated Capsule |
| |
| Diltiazem |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of MK-6552 | Blood samples will be collected to determine the Cmax of MK-6552 in plasma. | Pre-dose and at designated time points up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience and Adverse Event (AEs) | 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. | Up to approximately 20 days |
| Number of Participants Who Discontinue Study Due to an AE |
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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 |
|---|---|---|---|---|---|---|
| ICON (Site 0001) | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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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 Extended-Release Capsule |
|
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. |
| Up to approximately 20 days |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 | Blood samples will be collected to determine the AUC0-inf of MK-6552 in plasma. | Pre-dose and at designated time points up to 96 hours post dose |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552 | Blood samples will be collected to determine the AUC0-24 of MK-6552 in plasma. | Pre-dose and at designated time points up to 24 hours post dose |
| Time to Maximum Plasma Concentration (Tmax) of MK-6552 | Blood samples will be collected to determine the Tmax of MK-6552 in plasma. | Pre-dose and at designated time points up to 96 hours post dose |
| Concentration of MK-6552 at 6 Hours Postdose (C6h) | Blood samples will be collected to determine the C6h of MK-6552 in plasma. | Pre-dose and at designated time points up to 6 hours post dose |
| Concentration of MK-6552 at 8 Hours Postdose (C8h) | Blood samples will be collected to determine the C8h of MK-6552 in plasma. | Pre-dose and at designated time points up to 8 hours post dose |
| Apparent Clearance (CL/F) of MK-6552 | Blood samples will be collected to determine the CL/F of MK-6552 in plasma. | Pre-dose and at designated time points up to 96 hours post dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552 | Blood samples will be collected to determine the Vz/F of MK-6552 in plasma. | Pre-dose and at designated time points up to 96 hours post dose |
| Apparent Terminal Half-Life (t1/2) of MK-6552 | Blood samples will be collected to determine the t1/2 of MK-6552 in plasma. | Pre-dose and at designated time points up to 96 hours post dose |