drugset / Trial / NCT01448200

A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1

NCT01448200

Phase 1 Completed 82 enrolled Presidio Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.

Timeline

Start
2011-10
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ravidasvir Small molecule