The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Oral Tablet
Labcorp Clinical Research Unit Inc. (Site 0001)
Honolulu, Hawaii, United States
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib
Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib
Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib
Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
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Maximum Observed Concentration (Cmax) of Nemtabrutinib
Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib
Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.
Time frame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 30 days
Number of Participants Who Discontinue the Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 14 days