drugset / Trial / NCT01497327

Open-Label Hepatic Impairment Study

NCT01497327

Phase 1 Completed 24 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.

Timeline

Start
2011-07
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PSI-352938 Small molecule 300 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral