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

NCT07232589 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1026-022MK-1026-022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib

  Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.

  Up to approximately 4 weeks

• Maximum Plasma Concentration (Cmax) of Nemtabrutinib

  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

  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

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

  Up to approximately 4 weeks

• Apparent Terminal Half-life (t1/2) of Nemtabrutinib

  Blood samples will be collected to determine the t1/2 of nemtabrutinib.

  Up to approximately 4 weeks

• Apparent Clearance (CL/F) of Nemtabrutinib

  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

  Blood samples will be collected to determine the Vz/F of nemtabrutinib.

  Up to approximately 4 weeks

Secondary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 5 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 3 weeks

Study Arms (2)

Period 1: Nemtabrutinib

EXPERIMENTAL

Participants will receive nemtabrutinib followed by a protocol specified wash-out period.

Drug: Nemtabrutinib

Period 2: Diltiazem + Nemtabrutinib

EXPERIMENTAL

Participants will receive diltiazem plus nemtabrutinib.

Drug: Nemtabrutinib; Drug: Diltiazem

Interventions

Nemtabrutinib DRUG

Oral administration

Also known as: MK-1026, ARQ 531

Period 1: Nemtabrutinib; Period 2: Diltiazem + Nemtabrutinib

Diltiazem DRUG

Oral administration

Period 2: Diltiazem + Nemtabrutinib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Fortea CRU Madison ( Site 0001)

Madison, Wisconsin, 53704, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ARQ531; Diltiazem

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 8, 2025
• Primary Completion: May 4, 2026
• Study Completion (Estimated): May 16, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)