Nemtabrutinib
Drug25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.
Other names: MK-1026, ARQ 531
NCT Number: NCT06442436
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Clinical Pharmacology of Miami ( Site 0003), Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.
Other names: MK-1026, ARQ 531
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
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
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
The AUC0-last of nemtabrutinib in plasma will be determined in each arm.
Time frame: 24 hours postdose
The C24 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
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
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
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
The Vz/F of nemtabrutinib in plasma will be determined in each arm.
Time frame: Up to ~15 days
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
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.
Contact information is provided by the study sponsor or research team.
Merck Sharp & Dohme LLC
Industry
A Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Moderate Hepatic Impairment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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