Clinical trial NCT06647628: A Clinical Study of MK-1708 in Healthy Elderly Participants (MK-1708-005)
Official title: A Randomized, Double Blind Clinical Trial to Assess Safety, Tolerability and Pharmacokinetics of MK-1708 in Healthy Elderly Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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 exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy). Participants with definitively treated disease who, in the opinion of the study investigator, are highly unlikely to have a recurrence for the duration of the study may be enrolled at the discretion of the investigator

Primary outcomes:
measure: Number of participants with ≥1 adverse event (AE)
timeFrame: Up to 14 days after the last dose
measure: Number of participants discontinuing study therapy due to AE
timeFrame: Up to ~2 weeks
measure: Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of multiple MK-1708 doses
timeFrame: At designated time points up to ~2 weeks
measure: Maximum plasma concentration (Cmax) of multiple MK-1708 doses
timeFrame: At designated time points up to ~20 days
measure: Time to maximum plasma concentration (Tmax) of multiple MK-1708 doses
timeFrame: At designated time points up to ~20 days
measure: Concentration 24 hours postdose (C24) of multiple MK-1708 doses
timeFrame: At designated time points up to ~2 weeks
measure: Apparent oral clearance (CL/F) of multiple MK-1708 doses, at steady state
timeFrame: At designated time points up to ~20 days
measure: Apparent volume of distribution (Vz/F) of multiple MK-1708 doses, at steady state
timeFrame: At designated time points up to ~20 days
measure: Apparent terminal half-life (t½) of multiple MK-1708 doses
timeFrame: At designated time points up to ~20 days
measure: AUC0-24 accumulation ratio of multiple MK-1708 doses
timeFrame: At designated time points up to ~2 weeks
measure: Cmax accumulation ratio of multiple MK-1708 doses
timeFrame: At designated time points up to ~20 days
measure: C24 accumulation ratio of multiple MK-1708 doses
timeFrame: At designated time points up to ~2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0001)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Study Director
role: STUDY_DIRECTOR
References: