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Completed

NCT Number: NCT06625840

A Study of MK-1167 in Healthy Elderly Participants (MK-1167-004)

The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.

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Key information

Conditions

Healthy

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International (Site 0001)

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

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

The main inclusion criteria include but are not limited to the following:

  • Be in good health

The main exclusion criteria include but are not limited to the following:

  • History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • History of cancer (malignancy).

Treatment and study plan

MK-1167

Drug

Oral Administration

Placebo

Drug

Oral Administration

Primary outcomes

  1. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to approximately 41 days

    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.

  2. Number of Participants Discontinuing Study Treatment due to an AE

    Time frame: Up to approximately 16 days

    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.

  3. Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1167 after Multiple Doses

    Time frame: Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16

    Blood samples will be collected to determine the AUC0-24 of MK-1167.

  4. Maximum Concentration (Cmax) of MK-1167 after Multiple Doses

    Time frame: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16

    Blood samples will be collected to determine the Cmax of MK-1167.

  5. Concentration at 24 hours (C24) of MK-1167 after Multiple Doses

    Time frame: 24 hours postdose on days 1, 8 and 16

    Blood samples will be collected to determine the C24 of MK-1167.

  6. Time to reach maximum concentration (Tmax) of MK-1167 after Multiple Doses

    Time frame: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16

    Blood samples will be collected to determine the Tmax of MK-1167.

  7. Apparent Clearance (CL/F) of MK-1167 after Multiple Doses

    Time frame: Predose and at designated timepoints up to 600 hours postdose on day 16

    Blood samples will be collected to determine the CL/F of MK-1167.

  8. Volume of Distribution (Vz/F) of MK-1167 at Steady State after Multiple Doses

    Time frame: Predose and at designated timepoints up to 600 hours postdose on day 16

    Blood samples will be collected to determine the Vz/F of MK-1167.

  9. Apparent Half Life (t½) of MK-1167 after Multiple Doses

    Time frame: Predose and at designated timepoints up to 600 hours postdose on day 16

    Blood samples will be collected to determine the t½ of MK-1167.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 in Healthy Elderly Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

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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