Open-Label Study Evaluating How Nemtabrutinib Is Processed in People With Severe Kidney Disease

What This Trial Is About

Researchers are studying how nemtabrutinib, a drug taken by mouth, behaves in the bodies of people with severe kidney disease compared to healthy individuals. This Phase 1 trial aims to understand the drugs absorption, distribution, metabolism, and elimination, focusing on participants with stable severe renal impairment and healthy volunteers. The study is sponsored by Merck Sharp & Dohme LLC and involves a single-dose administration. All participants receive one oral dose of nemtabrutinib on the first day of the study. The trial monitors the drug concentration in plasma at several timepoints up to around 336 hours after dosing, assessing various pharmacokinetic measures such as the area under the concentration-time curve, maximum concentration, and clearance. Safety is evaluated by tracking any adverse events and study discontinuations over approximately 15 days. Participants will undergo assessments including plasma sampling for drug levels at specific intervals following dosing. Researchers will evaluate drug levels, timing of peak concentration, half-life, and other pharmacokinetic parameters. Safety monitoring for adverse events continues for about two weeks post-dose. The entire participation period involves a single-dose administration followed by monitoring and sample collection up to around 14 days.

A Clinical Trial of Nemtabrutinib in Participants With Severe Kidney Disease (MK-1026-027)