R7128 is being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:
-- Part 1 is a single ascending dose study of R7128 conducted in 46
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
-- 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
-- No hematological or la
|SOURCE Pharmasset, Inc.|
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