drugset / Trial / NCT03369002

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects

NCT03369002

Phase 1 Completed 32 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.

Timeline

Start
2017-11-27
Primary completion
2018-05-15
Completion
2018-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Seladelpar Small molecule 10 mg Oral

Indications

No indication recorded.