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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-015 | Other Identifier | MSD |
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The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hepatic Impairment (Group 1) | Experimental | All participants will receive a single dose of MK-8527 on Day 1. |
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| Moderate Hepatic Impairment (Group 2) | Experimental | All participants will receive a single dose of MK-8527 on Day 1. |
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| Healthy (Group 3) | Experimental | All participants will receive a single dose of MK-8527 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of MK-8527 | Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527. | Predose and at designated timepoints up to 168 hours post dose |
| Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527 | Plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-8527. | Predose and at designated timepoints up to 168 hours post dose |
| Maximum Observed Concentration (Cmax) of MK-8527 | Plasma samples will be collected at pre-specified timepoints to determine the Cmax of MK-8527. | Predose and at designated timepoints up to 168 hours post dose |
| Time to Maximum Concentration (Tmax) of MK-8527 | Plasma samples will be collected at pre-specified timepoints to determine the Tmax of MK-8527. | Predose and at designated timepoints up to 168 hours post dose |
| Apparent Terminal Half-life (t1/2) of MK-8527 | Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527. | Predose and at designated timepoints up to 168 hours post dose |
| Apparent Clearance (CL/F) of MK-8527 | Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527. | Predose and at designated timepoints up to 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to approximately 29 days |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
All participants:
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
Healthy Control Participants (Group 3):
- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants:
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Trials ( Site 0001) | Chandler | Arizona | 85225 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 | Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527. | Predose and at designated timepoints up to 168 hours post dose |
| Number of Participants Who Discontinue Study Due to an AE | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to approximately 29 days |
| AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs) | Blood samples will be collected to determine the AUC0-inf of MK-8527-TP. | Predose and at designated timepoints up to 672 hours post dose |
| Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs | Blood samples will be collected to determine the AUC0-672 of MK-8527-TP. | At designated timepoints pre dose and up to approximately 672 hours post dose |
| Cmax of MK-8527-TP in PBMCs | Blood samples will be collected to determine the Cmax of MK-8527-TP. | Predose and at designated timepoints up to 672 hours post dose |
| Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs | Blood samples will be collected to determine the C672 of MK-8527-TP. | Predose and at designated timepoints up to 672 hours post dose |
| Tmax of MK-8527-TP in PBMCs | Blood samples will be collected to determine the Tmax of MK-8527-TP. | Predose and at designated timepoints up to 672 hours post dose |
| T1/2 of MK-8527-TP in PBMCs | Blood samples will be collected to determine the Tmax of MK-8527-TP. | Predose and at designated timepoints up to 672 hours post dose |