Study Evaluating the Processing and Safety of D-2570 in Adults With and Without Liver Problems

What this Trial Is About

Researchers are studying how the drug D-2570 is processed in the body and its safety in adults who have liver problems compared to those with normal liver function. This single-center, non-randomized, open-label study evaluates the pharmacokinetic profile of D-2570, focusing on how the drug moves through the body in different participants. The study includes adults aged 18 to 70 years, both with hepatic impairment and healthy liver function. Participants receive a single oral dose of D-2570 during the study. The study is organized into parallel groups, with participants with liver impairment enrolled first, followed by those with normal liver function. Researchers will monitor how the drug is absorbed, distributed, metabolized, and cleared, using blood samples collected up to 192 hours after dosing. During participation, individuals will undergo assessments to measure drug levels and safety, including monitoring for adverse events up to 9 days after dosing. The study tracks several key pharmacokinetic parameters such as time to maximum plasma concentration, maximum concentration, half-life, area under the curve, clearance, and volume of distribution. The entire study is expected to conclude by November 2026, with a primary completion date in October 2026.

A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function