NCT01928147

A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients

A Phase Ia and Ib Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Antiviral Efficacy of PPI-383 in Healthy Adults and Hepatitis C Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Presidio Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 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-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	PPI-383
DRUG	Placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-07-01
• Completion: 2015-11-01
• First posted: 2013-08-23
• Last updated: 2015-11-26

Locations

6 sites across 2 countries: Mauritius, United Kingdom