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healthy volunteers. The primary objective of Part 1 is to assess the
safety, tolerability and pharmacokinetics of R7128 following single
ascending doses under fasting conditions. The secondary objective of
Part 1 is to explore the effect of food on the pharmacokinetics of
R7128. Preliminary data from the single ascending dose portion of the
study indicate:
- All doses of R7128 studied were generally safe and well-tolerated.
- All patients completed the study, and none experienced
gastrointestinal adverse events or serious adverse events during
the study.
- No hematological or laboratory abnormalities of clinical
significance were noted.
- Part 2 is a multiple ascending dose study of R7128 conducted in 40
patients chronically infected with HCV genotype 1 who have previously
failed interferon therapy. The primary objective of Part 2 is to
assess the safety, tolerability and pharmacokinetics of R7128 after
once-daily or twice-daily dosing for 14 days. The secondary objective
is to assess antiviral activity by measuring the change in HCV RNA.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The World Health Organization estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
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