Healthy
Conditions
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.
Interventions
DRUGDigoxin
Oral administration
DRUGNemtabrutinib
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 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. |
Countries
United States
Outcome results
None listed