Study Assesses BI 456906 Absorption in People with Kidney Impairment
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
Background
Understanding how new drugs are processed by the body, known as pharmacokinetics, is crucial for ensuring drug safety and efficacy. For individuals with renal impairment (kidney problems), drug metabolism and excretion can be significantly altered, potentially leading to higher drug levels and increased side effects. This Phase 1 study aimed to evaluate the pharmacokinetics, safety, and tolerability of BI 456906 in participants with mild, moderate, and severe renal impairment compared to those with normal kidney function. This research addresses a critical gap in understanding how this novel compound behaves in a vulnerable patient population.
Study Design
Population
Participants with mild, moderate, and severe renal impairment, and those with normal kidney function.
Intervention
BI 456906, dose and route not specified, single-dose administration.
Comparator
Participants with normal kidney function.
Outcome
Pharmacokinetics, safety, and tolerability of BI 456906.