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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1167-004 | Other Identifier | MSD |
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The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A | Experimental | Participants receive a loading dose of MK-1167 or Placebo orally on day 1, followed by a once daily (QD) maintenance dose orally on days 2 to 16. |
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| Panel B | Experimental | Participants receive a loading dose of MK-1167 or Placebo orally on days 1 to 3, followed by a QD maintenance dose orally on days 4 to 16. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1167 | Drug | Oral Administration |
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| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. | Up to approximately 41 days |
| Number of Participants Discontinuing Study Treatment due to an AE | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. | Up to approximately 16 days |
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1167 after Multiple Doses | Blood samples will be collected to determine the AUC0-24 of MK-1167. | Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16 |
| Maximum Concentration (Cmax) of MK-1167 after Multiple Doses | Blood samples will be collected to determine the Cmax of MK-1167. | Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16 |
| Concentration at 24 hours (C24) of MK-1167 after Multiple Doses | Blood samples will be collected to determine the C24 of MK-1167. | 24 hours postdose on days 1, 8 and 16 |
| Time to reach maximum concentration (Tmax) of MK-1167 after Multiple Doses |
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The main inclusion criteria include but are not limited to the following:
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 |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International (Site 0001) | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Drug |
Oral Administration |
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Blood samples will be collected to determine the Tmax of MK-1167. |
| Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16 |
| Apparent Clearance (CL/F) of MK-1167 after Multiple Doses | Blood samples will be collected to determine the CL/F of MK-1167. | Predose and at designated timepoints up to 600 hours postdose on day 16 |
| Volume of Distribution (Vz/F) of MK-1167 at Steady State after Multiple Doses | Blood samples will be collected to determine the Vz/F of MK-1167. | Predose and at designated timepoints up to 600 hours postdose on day 16 |
| Apparent Half Life (t½) of MK-1167 after Multiple Doses | Blood samples will be collected to determine the t½ of MK-1167. | Predose and at designated timepoints up to 600 hours postdose on day 16 |