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The purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it. The study will also measure what happens to MK-1708 in a healthy elderly person's body over time (pharmacokinetic or PK study). Researchers will learn if at least 1 dose level of MK-1708 will be safe, well-tolerated, and will be above a certain level in people's blood after 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1708 Dosage 1 | Experimental | Participants receive multiple doses of MK-1708 dosage 1. |
|
| MK-1708 Dosage 2 | Experimental | Participants receive multiple doses of MK-1708 dosage 2. |
|
| Placebo | Placebo Comparator | Participants receive multiple doses of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1708 | Drug | MK-1708 oral suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ≥1 adverse event (AE) | Up to 14 days after the last dose | |
| Number of participants discontinuing study therapy due to AE | Up to ~2 weeks | |
| Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of multiple MK-1708 doses | At designated time points up to ~2 weeks | |
| Maximum plasma concentration (Cmax) of multiple MK-1708 doses | At designated time points up to ~20 days | |
| Time to maximum plasma concentration (Tmax) of multiple MK-1708 doses | At designated time points up to ~20 days | |
| Concentration 24 hours postdose (C24) of multiple MK-1708 doses | At designated time points up to ~2 weeks | |
| Apparent oral clearance (CL/F) of multiple MK-1708 doses, at steady state | At designated time points up to ~20 days | |
| Apparent volume of distribution (Vz/F) of multiple MK-1708 doses, at steady state | At designated time points up to ~20 days | |
| Apparent terminal half-life (t½) of multiple MK-1708 doses | At designated time points up to ~20 days | |
| AUC0-24 accumulation ratio of multiple MK-1708 doses |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, Hallandale Beach ( Site 0001) | Hallandale | Florida | 33009 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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8 participants will be randomized to receive either placebo or MK-1708 dose level 1, then 8 participants will be randomized to receive either placebo or MK-1708 dose level 2.
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| Placebo |
| Drug |
Placebo oral suspension |
|
| At designated time points up to ~2 weeks |
| Cmax accumulation ratio of multiple MK-1708 doses | At designated time points up to ~20 days |
| C24 accumulation ratio of multiple MK-1708 doses | At designated time points up to ~2 weeks |