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

NCT06625827 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1026-012MK-1026-012
• 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 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  Blood samples will be collected to determine the AUC0-Inf of digoxin.

  At designated timepoints (up to approximately 7 days)

Secondary Outcomes (9)

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin

  At designated timepoints (up to approximately 7 days)

• Maximum Plasma Concentration (Cmax) of Digoxin

  At designated timepoints (up to approximately 7 days)

• Plasma Concentration 24 Hours Postdose (C24) of Digoxin

  At designated timepoints (up to approximately 24 hours)

• Time to Maximum Plasma Concentration (Tmax) of Digoxin

  Predose and at designated timepoints (up to approximately 7 days)

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

  At designated timepoints (up to approximately 7 days)

Study Arms (2)

Digoxin

EXPERIMENTAL

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

Drug: Digoxin

Digoxin + Nemtabrutinib

EXPERIMENTAL

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

Drug: Digoxin; Drug: Nemtabrutinib

Interventions

Digoxin DRUG

Oral administration

Digoxin; Digoxin + Nemtabrutinib

Nemtabrutinib DRUG

Oral administration

Also known as: MK-1026, ARQ 531

Digoxin + Nemtabrutinib

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

ICON (Site 0001)

Lenexa, Kansas, 66219, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Digoxin; ARQ531

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: November 7, 2023
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)