This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15
Time frame: Baseline and Day 15
Percentage of participants experiencing adverse events (AEs)
Time frame: Up to 28 days
Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Up to 28 days
Percentage of participants experiencing dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Time frame: Up to 28 days
Change in HCV RNA level from Baseline to Day 28
Time frame: Baseline and Day 28
Percentage of participants with undetectable HCV RNA at Day 15
Time frame: Day 15
Percentage of participants with undetectable HCV RNA at Day 28
Time frame: Day 28
Percentage of participants experiencing virologic breakthrough while on study therapy
Time frame: Up to 28 days
Change in alanine aminotransferase (ALT) level from Baseline to Day 15
Time frame: Baseline and Day 15
Change in ALT level from Baseline to Day 28
Time frame: Baseline and Day 28
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RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Maximum concentration (Cmax)
Time frame: Up to 28 days
Time to maximum concentration (Tmax)
Time frame: Up to 28 days
Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)
Time frame: Up to 28 days
AUC from time zero to infinity (AUC0-~)
Time frame: Up to 28 days
Trough concentration (Ctrough)
Time frame: Up to 28 days
Observed terminal half-life (Thalf)
Time frame: Up to 28 days