Skip to main content
OpenTrials
Completed

NCT Number: NCT06625827

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON (Site 0001)

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Digoxin

Drug

Oral administration

Nemtabrutinib

Drug

Oral administration

Other names: MK-1026, ARQ 531

Primary outcomes

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

    Time frame: At designated timepoints (up to approximately 7 days)

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

Secondary outcomes

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

    Time frame: At designated timepoints (up to approximately 7 days)

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

  2. Maximum Plasma Concentration (Cmax) of Digoxin

    Time frame: At designated timepoints (up to approximately 7 days)

    Blood samples will be collected to determine the Cmax of digoxin.

  3. Plasma Concentration 24 Hours Postdose (C24) of Digoxin

    Time frame: At designated timepoints (up to approximately 24 hours)

    Blood samples will be collected to determine the C24 of digoxin.

  4. Time to Maximum Plasma Concentration (Tmax) of Digoxin

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

    Blood samples will be collected to determine the Tmax of digoxin.

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

    Time frame: At designated timepoints (up to approximately 7 days)

    Blood samples will be collected to determine t1/2 of digoxin.

  6. Apparent Clearance (CL/F) of Digoxin

    Time frame: At designated timepoints (up to approximately 7 days)

    Blood samples will be collected to determine the CL/F of digoxin.

  7. Apparent Volume of Distribution (Vz/F) of Digoxin

    Time frame: At designated timepoints (up to approximately 7 days)

    Blood samples will be collected to determine the Vz/F of digoxin.

  8. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 8 weeks

    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.

  9. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.