Pharmasset Completes Enrollment of Phase I Study of R7128

Pharmasset announced that it has completed patient enrollment of the ongoing multiple ascending dose study of R7128 for the treatment of hepatitis C virus (HCV).

According to Pharmasset, R7128, a nucleoside polymerase inhibitor of HCV, is currently being evaluated in a Phase I clinical trial as part of Pharmasset’s collaboration with Roche.

The primary objective of the multiple ascending dose study is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days in a maximum of 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy, the company said.

The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA in these patients, the company added.

Pharmasset said it expects to release preliminary 14-day safety and efficacy treatment data from the multiple ascending dose study in September.

The Phase I clinical trial is a multiple center, observer-blinded, randomized, 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.