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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01448200

Run by

Presidio Pharmaceuticals, Inc.

People needed

82

Starts

2011-10-01

Expected to finish

2012-11-01

Last updated by the study team

2012-11-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

• Investigational site — Costa Mesa, California, United States
• Investigational site — Sacramento, California, United States
• Investigational site — San Francisco, California, United States
• Investigational Site — San Antonio, Texas, United States
• Investigational site — Canberra, Australia
• Investigational site — Auckland, New Zealand
• Investigational site — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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