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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-012 | Other Identifier | MSD |
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The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8527 + CBZ | Experimental | Treatment A (Period 1): Participants will receive a single dose of MK-8527 on Day 1. Treatment B (Period 2): Participants will receive CBZ twice a day on Days 1 to 20 and a single dose of MK-8527 coadministered with the morning dose of CBZ on Day 14. A washout period will separate Treatments A and B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Oral Tablet |
| |
| CBZ |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527 | Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma | Predose and at designated timepoints (up to 168 hours postdose) |
| Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-8527 | Blood samples will be collected to determine the AUC0-last of MK-8527 in plasma | Predose and at designated timepoints (up to 168 hours postdose) |
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8527 | Blood samples will be collected to determine the AUC0-24 of MK-8527 in plasma | Predose and at designated timepoints (up to 24 hours postdose) |
| Area Under the Concentration-Time Curve from 0 to 168 hours (AUC0-168) of MK-8527 | Blood samples will be collected to determine the AUC0-168 of MK-8527 in plasma | Predose and at designated timepoints (up to 168 hours postdose) |
| Maximum Observed Plasma Concentration (Cmax) of MK-8527 | Blood samples will be collected to determine the Cmax of MK-8527 in plasma | Predose and at designated timepoints (up to 168 hours postdose) |
| Time to Maximum Observed Plasma Concentration (Tmax) of MK-8527 | Blood samples will be collected to determine the Tmax of MK-8527 in plasma | Predose and at designated timepoints (up to 168 hours 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 the study intervention, whether or not considered related to the study intervention. | Up to approximately 60 days |
| Number of Participants Who Discontinue Study Treatment Due to an AE |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to:
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
Has a history or presence of:
Shown to carry or be positive for HLA-A*11:01, HLA-A*31:01, HLA-B*15:02, HLA-B*15:08, HLA-B*15:11, HLA-B*15:21, HLA-B*15:30, or HLA-B*15:31 alleles.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Drug |
Oral Extended-release Capsule |
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| Apparent Terminal Half-Life (t1/2) of MK-8527 |
Blood samples will be collected to determine the t1/2 of MK-8527 in plasma |
| Predose and at designated timepoints (up to 168 hours postdose) |
| Apparent Clearance (CL/F) of MK-8527 | Blood samples will be collected to determine the CL/F of MK-8527 in plasma | Predose and at designated timepoints (up to 168 hours postdose) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 | Blood samples will be collected to determine the Vz/F of MK-8527 in plasma | Predose and at designated timepoints (up to 168 hours postdose) |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Up to approximately 30 days |