New Dosing Study for HCV Genotype 1
March 12, 2007
Pharmasset Initiates Multiple Ascending Dose Study of R7128 in Patients Chronically Infected With HCV Genotype 1
PR Newswire Europe (inc. UK Disclose) – Feb. 28, 2007
PRINCETON, New Jersey, February 28 /PRNewswire/ —
Pharmasset initiated the multiple ascending dose portion of an on-going Phase 1 clinical trial evaluating R7128 in up to 40 patients chronically infected with hepatitis C virus (HCV) genotype 1. The primary objective of this part of the study, being conducted in collaboration with Roche, is to assess the safety, tolerability and pharmacokinetics of multiple doses of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy of R7128 by measuring the decrease in HCV viral load. As a result of the initiation of the multiple ascending dose portion of this study, Pharmasset triggered a US$5.0 million milestone payment from Roche.
Pharmasset and Roche recently completed part 1 of this Phase 1 study in 38 healthy volunteers who received single ascending doses of R7128. The effect of food on R7128 was also assessed. Preliminary data from the single ascending dose portion of the study indicate:
- All doses of R7128 studied were generally 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.
The preliminary safety and pharmacokinetic data from part 1 of the study supported progression of R7128 into part 2 of the study in patients chronically infected with HCV genotype 1.
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated excellent 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 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 I 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 study is comprised of two parts:
- Part 1 is a single ascending dose study being conducted in up to 38 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.
- Part 2 is a multiple ascending dose study being conducted in up to 40 patients chronically infected with HCV genotype 1. 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 efficacy bymeasuring the decrease in HCV viral load.
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