Hepatitis C, Chronic Clinical Trial
Official title:
A Randomized, Single Blind, Dose Escalation, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of Repeat Doses of GSK2878175 in Subjects With Chronic Hepatitis C.
GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment
of chronic hepatitis C virus (HCV) infection. The purpose of this study is to investigate the
effects of GSK2878175, at different doses in men and women infected with chronic hepatitis C
virus. The study will investigate how much of the drug gets into the blood stream and how
long the body takes to get rid of it. The study will also investigate if GSK2878175 has any
important side effects. The study will also measure what effect GSK2878175 has on the
hepatitis C virus infection after taking the study medication for 2 days. Approximately 44
people will take part in this study. Depending on the type of chronic hepatitis C infection a
subject will be enrolled into 1 of 4 groups randomly. Each group will participate in one
dosing session. One dosing session consists of GSK2878175 or a placebo (sugar pill) given
once per day for 2 days.
Group A, B, and C is made up of 8 participants per group. In each of these groups 6
participants will receive GSK2878175 and 2 participants will receive placebo. Group D is made
up of 20 participants. 15 participants will receive GSK2878175 and 5 participants will
receive placebo. The treatment groups will be dosed in sequence. Group A will be the first to
take the study medication, then Group B, and so on. The plan is to dose subjects in Group A
with 10 mg, Group B with 30 mg, Group C with 60 mg, and Group D with 60 mg of GSK2878175 or
placebo. The next treatment group's actual dose will be decided after looking at the results
from the previous group. The doses may therefore be higher or lower than planned depending on
the previous group's results. The number of participants enrolled in the next group may also
change depending on the results from the previous group.
n/a
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