Nemtabrutinib for Liver Disease
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants with moderate hepatic impairment must have been on a stable medication regimen for at least 1 month and may need to stop certain medications for a specific period. Healthy control participants must refrain from using any medications, including prescription, nonprescription, and herbal remedies.
What data supports the effectiveness of the drug Nemtabrutinib for liver disease?
How is the drug Nemtabrutinib unique for treating liver disease?
Nemtabrutinib is a Bruton's tyrosine kinase inhibitor, which is a different mechanism of action compared to other treatments for liver disease, such as tivantinib, a MET inhibitor. This unique approach may offer a novel way to address liver disease by targeting specific pathways involved in the condition.12678
What is the purpose of this trial?
The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemabrutinib (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.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults with a BMI of 18.0-40.0 who have chronic, stable moderate liver disease (Class B) and are not pregnant or breastfeeding. Participants must be in good general health, agree to use contraception, and provide informed consent.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of 25 mg nemtabrutinib
Pharmacokinetic Monitoring
Plasma pharmacokinetics of nemtabrutinib are measured at multiple time points postdose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nemtabrutinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University