drugset / Trial / NCT05393076

Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls

NCT05393076

Phase 1 Completed 8 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function. All participants in both cohorts (moderate hepatic impairment and matched healthy controls) will receive a single dose of the study drug, linerixibat. The purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) and safety of linerixibat.

Timeline

Start
2022-07-19
Primary completion
2022-12-06
Completion
2022-12-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Linerixibat Small molecule

Indications

No indication recorded.