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Completed

NCT Number: NCT07232589

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortea CRU Madison ( Site 0001)

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Nemtabrutinib

Drug

Oral administration

Other names: MK-1026, ARQ 531

Diltiazem

Drug

Oral administration

Primary outcomes

  1. 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.

  2. Maximum Plasma Concentration (Cmax) of Nemtabrutinib

    Time frame: Up to approximately 4 weeks

    Blood samples will be collected to determine the Cmax of nemtabrutinib.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Jun 29, 2026

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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