Hepatitis C Clinical Trial
Official title:
A Randomized, Double Blind, Dose Escalation, Fusion, First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2485852 in Chronically Infected Hepatitis C Subjects
GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed
for the treatment of chronic HCV infection. HBI115040 is the first administration of
GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and
antiviral profile. The study design is a fusion of single and repeat dosing cohorts in HCV
infected subjects to evaluate the safety, pharmacokinetics, and antiviral activity of
GSK2485852.
HBI115040 describes a Phase I, randomized, double-blind, placebo-controlled, dose escalation
fusion study to determine the safety, tolerability, pharmacokinetic, and antiviral profile of
GSK2485852 in single doses (Part 1), repeat doses (Part 2), and ritonavir co-administration
(Part 3) in chronically infected HCV subjects. The study will also explore the effect of a
moderate (30%) fat meal on pharmacokinetic endpoints in HCV subjects in Part 1.
n/a
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