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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2024-01-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Digoxin

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

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Oral administration

Digoxin + Nemtabrutinib

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

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Oral administration

Nemtabrutinib

Intervention Type DRUG

Oral administration

Interventions

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Digoxin

Oral administration

Intervention Type DRUG

Nemtabrutinib

Oral administration

Intervention Type DRUG

Other Intervention Names

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MK-1026 ARQ 531

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes