Healthy
Conditions
Brief summary
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.
Interventions
DRUGMK-1708
MK-1708 oral suspension
DRUGPlacebo
Placebo oral suspension
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive
Exclusion criteria
The key
Design outcomes
Primary
| Measure | 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 | 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 |
Countries
United States
Outcome results
None listed