NCT06625840

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2023

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 1, 2024

Last Update Submit

October 1, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • Number of Participants Experiencing an Adverse Event (AE)

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

Panel A

EXPERIMENTAL

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: MK-1167Drug: Placebo

Panel B

EXPERIMENTAL

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: MK-1167Drug: Placebo

Interventions

MK-1167DRUG

Oral Administration

Panel APanel B
PlaceboDRUG

Oral Administration

Panel APanel B

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be in good health

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glendale, California, 91206, United States

Location

Related Links

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

September 18, 2023

Primary Completion

May 8, 2024

Study Completion

May 8, 2024

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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

More information

Locations

US(1)