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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Diltiazem; Drug: Nemtabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07232589

1026-022

MK-1026-022 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Period 1: Nemtabrutinib

Experimental group

Description:

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

Treatment:

Drug: Nemtabrutinib

Period 2: Diltiazem + Nemtabrutinib

Experimental group

Description:

Participants will receive diltiazem plus nemtabrutinib.

Treatment:

Drug: Nemtabrutinib

Drug: Diltiazem