A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Digoxin; Drug: Nemtabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06625827

1026-012

MK-1026-012 (Other Identifier)

Details and patient eligibility

About

The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

• Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
• Has a hypersensitivity to digoxin and/or to other digitalis preparations including inactive ingredients (eg, lactose, corn starch and potato starch)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Digoxin

Experimental group

Description:

Participants receive a single oral dose of digoxin (Treatment A).

Treatment:

Drug: Digoxin

Digoxin + Nemtabrutinib

Experimental group

Description:

Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B).

Treatment:

Drug: Nemtabrutinib

Drug: Digoxin