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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: MK-1708

• Registration Number: NCT06647628
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-18
• Study Start: 2024-11-04
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receive multiple doses of placebo.
MK-1708 Dosage 1	MK-1708	Participants receive multiple doses of MK-1708 dosage 1.
MK-1708 Dosage 2	MK-1708	Participants receive multiple doses of MK-1708 dosage 2.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Velocity Clinical Research, Hallandale Beach ( Site 0001); 🇺🇸 Hallandale Beach, Florida, United States