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

October 1, 2024 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A
Participants receive a loading dose of MK-1167 or Placebo orally on day 1, followed by a once daily (QD) maintenance dose orally on days 2 to 16.
Drug: Placebo
Oral Administration
Drug: MK-1167
Oral Administration
Experimental: Panel B
Participants receive a loading dose of MK-1167 or Placebo orally on days 1 to 3, followed by a QD maintenance dose orally on days 4 to 16.
Drug: Placebo
Oral Administration
Drug: MK-1167
Oral Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 41 days
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.
Up to approximately 16 days
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.
Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16
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.
Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
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.
24 hours postdose on days 1, 8 and 16
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.
Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
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.
Predose and at designated timepoints up to 600 hours postdose on day 16
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.
Predose and at designated timepoints up to 600 hours postdose on day 16
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.
Predose and at designated timepoints up to 600 hours postdose on day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

May 8, 2024

Study Completion (Actual)

May 8, 2024

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1167-004
  • MK-1167-004 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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