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Completed

NCT Number: NCT06647628

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

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.

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Key information

Conditions

Healthy

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research, Hallandale Beach ( Site 0001)

Hallandale, Florida, 33009, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-1708

Drug

MK-1708 oral suspension

Placebo

Drug

Placebo oral suspension

Primary outcomes

  1. Number of participants with ≥1 adverse event (AE)

    Time frame: Up to 14 days after the last dose

  2. Number of participants discontinuing study therapy due to AE

    Time frame: Up to ~2 weeks

  3. Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of multiple MK-1708 doses

    Time frame: At designated time points up to ~2 weeks

  4. Maximum plasma concentration (Cmax) of multiple MK-1708 doses

    Time frame: At designated time points up to ~20 days

  5. Time to maximum plasma concentration (Tmax) of multiple MK-1708 doses

    Time frame: At designated time points up to ~20 days

  6. Concentration 24 hours postdose (C24) of multiple MK-1708 doses

    Time frame: At designated time points up to ~2 weeks

  7. Apparent oral clearance (CL/F) of multiple MK-1708 doses, at steady state

    Time frame: At designated time points up to ~20 days

  8. Apparent volume of distribution (Vz/F) of multiple MK-1708 doses, at steady state

    Time frame: At designated time points up to ~20 days

  9. Apparent terminal half-life (t½) of multiple MK-1708 doses

    Time frame: At designated time points up to ~20 days

  10. AUC0-24 accumulation ratio of multiple MK-1708 doses

    Time frame: At designated time points up to ~2 weeks

  11. Cmax accumulation ratio of multiple MK-1708 doses

    Time frame: At designated time points up to ~20 days

  12. C24 accumulation ratio of multiple MK-1708 doses

    Time frame: At designated time points up to ~2 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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