The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Tablets, twice a day for 3 days
Tablets, twice a day for 3 days
Tablets, three times a day for 3 days
Fundacion de Investigacion de Diego
San Juan, Puerto Rico
Number of subjects with adverse events
Time frame: 1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Time frame: 1 week
Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2
Time frame: 1 week
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2
Time frame: 1 week
Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2
Time frame: 1 week
Viral load change from baseline to end of treatment
Time frame: 48 weeks
Genotypic resistance assessment and viral load change from baseline over time
Time frame: 48 weeks
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Tablets, twice a day for 3 days
Tablets, twice a day or three times a day for 3 days