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

NCT06647628 | Completed Phase 1 FDA Drug

• 1 other identifier: 1708-005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (3)

MK-1708 Dosage 1

EXPERIMENTAL

Participants receive multiple doses of MK-1708 dosage 1.

Drug: MK-1708

MK-1708 Dosage 2

EXPERIMENTAL

Participants receive multiple doses of MK-1708 dosage 2.

Drug: MK-1708

Placebo

PLACEBO COMPARATOR

Participants receive multiple doses of placebo.

Drug: Placebo

Interventions

MK-1708 DRUG

MK-1708 oral suspension

MK-1708 Dosage 1; MK-1708 Dosage 2

Placebo DRUG

Placebo oral suspension

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Is in good health before randomization
• Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Velocity Clinical Research, Hallandale Beach ( Site 0001)

Hallandale, Florida, 33009, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Study Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: November 4, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)