A Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Moderate Hepatic Impairment
Merck Sharp & Dohme LLC
Summary
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Has a body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive. * Is assigned male or female sex at birth. Participants assigned female sex at birth must not be pregnant or breast feeding and must be of nonchild bearing potential. * Who agrees to use contraception. * Has provided documented informed consent for the study. * Has a diagnosis of chronic (\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic impairment with features of cirrhosis due to any etiology (moderate HI only). * Has modera…
Interventions
- DrugNemtabrutinib
25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.
Locations (3)
- Clinical Pharmacology of Miami ( Site 0003)Miami, Florida
- Orlando Clinical Research Center ( Site 0001)Orlando, Florida
- Texas Liver Institute ( Site 0002)San Antonio, Texas