A Study of the Effect of Diltiazem on the Plasma Levels of Nemtabrutinib (MK-1026-022)

May 26, 2026 updated by: Merck Sharp & Dohme LLC

A Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants.

The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called diltiazem.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Fortea CRU Madison ( 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:

  • Be in good health
  • BMI between 18.5 and 32 kg/m2, inclusive

Exclusion Criteria:

  • History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological (history of a bleeding disorder, abnormal bleeding or a hereditary or acquired coagulation or platelet disorder), hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke, intercranial hemorrhage, 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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Period 1: Nemtabrutinib
Participants will receive nemtabrutinib followed by a protocol specified wash-out period.
Drug: Nemtabrutinib
Oral administration
Other Names:
  • MK-1026
  • ARQ 531
Experimental: Period 2: Diltiazem + Nemtabrutinib
Participants will receive diltiazem plus nemtabrutinib.
Drug: Nemtabrutinib
Oral administration
Other Names:
  • MK-1026
  • ARQ 531
Drug: Diltiazem
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
Time Frame: Up to approximately 4 weeks
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.
Up to approximately 4 weeks
Maximum Plasma Concentration (Cmax) of Nemtabrutinib
Time Frame: Up to approximately 4 weeks
Blood samples will be collected to determine the Cmax of nemtabrutinib.
Up to approximately 4 weeks
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Nemtabrutinib
Time Frame: Up to approximately 4 weeks
Blood samples will be collected to determine the AUC0-last of nemtabrutinib.
Up to approximately 4 weeks
Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib
Time Frame: Up to approximately 4 weeks
Blood samples will be collected to determine the Tmax of nemtabrutinib.
Up to approximately 4 weeks
Apparent Terminal Half-life (t1/2) of Nemtabrutinib
Time Frame: Up to approximately 4 weeks
Blood samples will be collected to determine the t1/2 of nemtabrutinib.
Up to approximately 4 weeks
Apparent Clearance (CL/F) of Nemtabrutinib
Time Frame: Up to approximately 4 weeks
Blood samples will be collected to determine the CL/F of nemtabrutinib.
Up to approximately 4 weeks
Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib
Time Frame: Up to approximately 4 weeks
Blood samples will be collected to determine the Vz/F of nemtabrutinib.
Up to approximately 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 5 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 5 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 3 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 3 weeks

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)

December 8, 2025

Primary Completion (Actual)

May 4, 2026

Study Completion (Actual)

May 16, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026-022
  • MK-1026-022 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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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