A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012)
- Registration Number
- NCT06625827
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Digoxin Digoxin Participants receive a single oral dose of digoxin (Treatment A). Digoxin + Nemtabrutinib Digoxin Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B). Digoxin + Nemtabrutinib Nemtabrutinib Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B).
- Primary Outcome Measures
Name Time Method Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the AUC0-Inf of digoxin.
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the AUC0-Last of digoxin.
Maximum Plasma Concentration (Cmax) of Digoxin At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the Cmax of digoxin.
Plasma Concentration 24 Hours Postdose (C24) of Digoxin At designated timepoints (up to approximately 24 hours) Blood samples will be collected to determine the C24 of digoxin.
Time to Maximum Plasma Concentration (Tmax) of Digoxin Predose and at designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the Tmax of digoxin.
Apparent Volume of Distribution (Vz/F) of Digoxin At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the Vz/F of digoxin.
Number of Participants Who Experience an Adverse Event (AE) 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.
Number of Participants Who Discontinue Study Due to an AE 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.
Apparent Terminal Half-life (t1/2) of Digoxin At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine t1/2 of digoxin.
Apparent Clearance (CL/F) of Digoxin At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the CL/F of digoxin.
Trial Locations
- Locations (1)
ICON (Site 0001)
🇺🇸Lenexa, Kansas, United States