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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
capsules
capsules
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
Safety and tolerability, as measured by clinical adverse events and laboratory assessments
Time frame: Part I, up to day 12; and Part II, up to day 17
PPI-668 plasma levels
Time frame: Part I, up to day 12; and Part II, up to day 17
serum HCV RNA levels
Time frame: Part II, up to day 17
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