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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Oral administration
Oral administration
ICON (Site 0001)
Lenexa, Kansas, United States
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.
Time frame: At designated timepoints (up to approximately 7 days)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At designated timepoints (up to approximately 7 days)
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Apparent Volume of Distribution (Vz/F) of Digoxin
Blood samples will be collected to determine the Vz/F of digoxin.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 8 weeks