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

A Study to Evaluate the Effect of Nemtabrutinib on the Pharmacokinetics of Digoxin in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Digoxin; Drug: Nemtabrutinib

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON (Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digoxin; Participants receive a single oral dose of digoxin (Treatment A).	Drug: Digoxin; Oral administration
Experimental: Digoxin + Nemtabrutinib; Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B).	Drug: Digoxin; Oral administration; Drug: Nemtabrutinib; Oral administration; Other Names: MK-1026; ARQ 531

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin	Blood samples will be collected to determine the AUC0-Last of digoxin.	At designated timepoints (up to approximately 7 days)
Maximum Plasma Concentration (Cmax) of Digoxin	Blood samples will be collected to determine the Cmax of digoxin.	At designated timepoints (up to approximately 7 days)
Plasma Concentration 24 Hours Postdose (C24) of Digoxin	Blood samples will be collected to determine the C24 of digoxin.	At designated timepoints (up to approximately 24 hours)
Time to Maximum Plasma Concentration (Tmax) of Digoxin	Blood samples will be collected to determine the Tmax of digoxin.	Predose and at designated timepoints (up to approximately 7 days)
Apparent Terminal Half-life (t1/2) of Digoxin	Blood samples will be collected to determine t1/2 of digoxin.	At designated timepoints (up to approximately 7 days)
Apparent Clearance (CL/F) of Digoxin	Blood samples will be collected to determine the CL/F of digoxin.	At designated timepoints (up to approximately 7 days)
Apparent Volume of Distribution (Vz/F) of Digoxin	Blood samples will be collected to determine the Vz/F of digoxin.	At designated timepoints (up to approximately 7 days)
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.	Up to approximately 8 weeks
Number of Participants Who Discontinue Study Due to an AE	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.	Up to approximately 8 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: 1026-012; MK-1026-012 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No