A Clinical Study of MK-1708 in Healthy Elderly Participants (MK-1708-005)

A Randomized, Double Blind Clinical Trial to Assess Safety, Tolerability and Pharmacokinetics of MK-1708 in Healthy Elderly Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: MK-1708

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-1708 Dosage 1; Participants receive multiple doses of MK-1708 dosage 1.	Drug: MK-1708; MK-1708 oral suspension
Experimental: MK-1708 Dosage 2; Participants receive multiple doses of MK-1708 dosage 2.	Drug: MK-1708; MK-1708 oral suspension
Placebo Comparator: Placebo; Participants receive multiple doses of placebo.	Drug: Placebo; Placebo oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Study Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1708-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes