The purpose of this study is to learn what happens to nemtabrutinib in a person's body when given to participants with severe kidney disease and to healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Oral administration
Floridian Clinical Research, LLC ( Site 0001)
Miami Lakes, Florida, United States
RECRUITINGArea Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the AUC0-inf of Nemtabrutinib in plasma.
Time frame: At designated timepoints up to approximately 336 hours postdose
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-last of Nemtabrutinib in plasma.
Time frame: At designated timepoints up to approximately 336 hours postdose
Area Under the Concentration Versus Time Curve from 0 to 24 Hours Postdose (AUC0-24) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-24 of Nemtabrutinib.
Time frame: Up to approximately 24 hours postdose
Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the (Cmax) of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Concentration at 24 Hours Postdose (C24) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the C24 of Nemtabrutinib.
Time frame: Up to approximately 24 hours postdose
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the (Tmax) of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
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Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the (t1/2) of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
Blood samples will be collected to determine the CL/F of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the Vz/F of Nemtabrutinib.
Time frame: At designated timepoints up to approximately 336 hours 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 study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 15 days
Number of Participants Who Discontinue From the Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue from the study due to an AE will be reported.
Time frame: Up to approximately 15 days