A phase Ib, multicentre, randomized, double-blind, cohort, placebo-controlled, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of PSI 938 (GS-0938), Sofosbuvir (GS-7977, PSI 7977) and their combination in treatment-naive patients with chronic hepatitis C genotype 1 infection.

Trial Profile

A phase Ib, multicentre, randomized, double-blind, cohort, placebo-controlled, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of PSI 938 (GS-0938), Sofosbuvir (GS-7977, PSI 7977) and their combination in treatment-naive patients with chronic hepatitis C genotype 1 infection.

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 24 Jan 2014

At a glance

  • Drugs PSI 938 (Primary) ; Sofosbuvir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Acronyms NUCLEAR
  • Most Recent Events

    • 28 Mar 2011 Results will be presented at EASL-2011 according to a Pharmasset media release.
    • 06 Jan 2011 Interim results for the PSI 938 300mg QD group presented in a Pharmasset media release
    • 06 Jan 2011 Patients now being enrolled in the second and third cohorts, and further data expected to be reported during the first quarter of 2011, according to a Pharmasset media release
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