The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemtabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control participants and to evaluate the safety and tolerability of nemtabrutinib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.
Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida, United States
RECRUITINGOrlando Clinical Research Center ( Site 0001)
Orlando, Florida, United States
RECRUITINGTexas Liver Institute ( Site 0002)
San Antonio, Texas, United States
RECRUITINGArea Under the Curve from Dosing to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
The AUC0-inf of nemtabrutinib in plasma will be determined in each arm.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Maximum Concentration (Cmax) of Nemtabrutinib in Plasma
The Cmax of nemtabrutinib in plasma will be determined in each arm.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Area Under the Curve from Dosing to last (AUC0-last) of Nemtabrutinib in Plasma
The AUC0-last of nemtabrutinib in plasma will be determined in each arm.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Concentration 24 (C24) Hours Postdose of Nemtabrutinib in Plasma
The C24 of nemtabrutinib in plasma will be determined in each arm.
Time frame: 24 hours postdose
Time to Maximum Concentration (Tmax) of Nemtabrutinib in Plasma
The Tmax of nemtabrutinib in plasma will be determined in each arm.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Apparent Terminal Half-life (t1/2) of Nemtabrutinib in Plasma
The t½ of nemtabrutinib in plasma will be determined in each arm.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Apparent Total Clearance (CL/F) of Nemtabrutinib in Plasma
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The CL/F of nemtabrutinib in plasma will be determined in each arm.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib in Plasma
The Vz/F of nemtabrutinib in plasma will be determined in each arm.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Number of Participants who Experience One or More Adverse Events (AEs)
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 experiencing AEs will be reported.
Time frame: Up to ~15 days
Number of Participants Who Discontinue From the Study Due to 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 discontinuing study treatment due to an AE will be reported.
Time frame: Up to ~15 days