A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-017)

January 9, 2025 updated by: Merck Sharp & Dohme LLC

A Study to Evaluate the Effect of Food on the Pharmacokinetics of the Nemtabrutinib Final Market Formulation 2 (FMF2) in Healthy Participants

The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Labcorp Clinical Research Unit Inc. (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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Inclusion criteria include, but are not limited to:

  • Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
  • Has a body mass index (BMI) 18.0 to 32.0 kg/m^2 (inclusive)

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

  • Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a 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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nemtabrutinib Treatment A
Participants receive a single dose of nemtabrutinib on Day 1 under fasted conditions (on an empty stomach after a 10-hour overnight fast)
Drug: Nemtabrutinib
Oral Tablet
Other Names:
  • MK-1026
  • ARQ-531
Experimental: Nemtabrutinib Treatment B
Participants receive a single dose of nemtabrutinib on Day 1 under fed conditions (after a high-fat meal)
Drug: Nemtabrutinib
Oral Tablet
Other Names:
  • MK-1026
  • ARQ-531

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)
Maximum Observed Concentration (Cmax) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib
Time Frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.
Predose and at designated timepoints (up to approximately 2 weeks postdose)
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to 30 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Up to 30 days
Number of Participants Who Discontinue the Study Intervention Due to an AE
Time Frame: Up to 14 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Up to 14 days

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)

October 2, 2023

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

February 16, 2024

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1026-017
  • MK-1026-17 (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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